Recalling Firm
PerkinElmer Life and Analytical Sciences, Wallac, OY
DePuy Mitek, Inc., a Johnson & Johnson Co.

Initial Firm Notification of Consignee or Public
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Distribution Pattern
Worldwide Distribution - US (Nationwide) and in the countries of Canada, Puerto Rico, United Arab Emirates, Philippines, and Europe.
Distributed in 20 US states: AL, AR, AZ, CA, CO, FL, GA, IL, IN, KS, KY, LA, MI, MO, NV, OH, OR, SC, TN, TX.
Distributed in the following U.S. states: FL, MA, MI, OH, OK TN, and Netherlands.
Worldwide Distribution in the states of AL, AZ, CA, CO, CT, FL, GA, IL, IN, KS, KY, LA, MA, MN, MO, MS, NC, NJ, NY, OH, OK, PA, PR, SC, SD, TN, TX, UT, VT, WA, WY. Distributed internationally to Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bangladesh, Barbados, Belarus, Belgium, Bosnia and Herzegovi, Botswana, Brazil, Brunei, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Egypt, Finland, France, Gaza and Jericho, Georgia, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jamaica, Jordan, Kazakhstan, Kenya, Kuwait, Kyrgyzstan, Latvia, Lebanon, Lithuania, Luxembourg, Malaysia, Maldives, Mexico, Morocco, Netherlands, Nigeria, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Republic of Yemen, Romania, Russia, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Switzerland, Taiwan, Tajikistan, Thailand, Tunisia, Turkey, Uganda, United Arab Emirates, Uganda, United Kingdom, Uruguay .
Nationwide and Canada, Mexico, and Thailand
US Nationwide Distribution in the states of OH, WA, CO
Distribution was made to medical facilities in AZ, CA, CT, FL, IL, IN, KS, KY, MI, MN, MO, NJ, NY, NC, OH, PA, TX, VA, and WA. There was no military/government distribution. Foreign distribution was made to Argentina, Australia, Austria, Belgium, Bosnia Herzeg, Colombia, Croatia, Denmark, France, Germany, India, Ireland, Israel, Italy, Japan, Mexico, New Zealand, Philippines, Poland, Republic Korea, Romania, Singapore, Slovakia, Spain, Sweden, Taiwan, Thailand, Turkey, UAE, and Vietnam.
Worldwide Distribution - US Nationwide and the countries of Brazil, Canada, Malaysia, Singapore, Taiwan, Thailand, Turkey
AL, AR, AZ, CA, CO, FL, GA, ID, IL, IN, KS, LA, MA, MD, MI, MN, NC, NE, NH, NJ, NY, OK, OR, PA, RI, SC, TX, UT, VA, WA, WY, and Hawaii Australia, Italy, Netherlands, Singapore, South Korea, United Kingdom, and Vietnam
Worldwide Distribution -- US, Brazil, Guatemala, Ecuador, Malaysia, Czech Republic, United Kingdom, Argentina, Honduras, Peru, Singapore, Denmark, Iceland, Chile, Nicaragua, Venezuela, Japan, Egypt, Israel, Canada, Panama, Taiwan, United Arab Emirates, Finland, Ireland, Mexico, Dominican Republic, Hong Kong, Austria, France, Italy, Costa Rica, Trinidad and Tobago, Australia, Bahrain, Georgia, Islamic Republic of Iran, El Salvador, Colombia, New Zealand, Belgium, Germany, Jordan, Norway, Russia, Pakistan, Slovakia, Portugal, South Africa, Oman, Saudi Arabia, Poland, Slovenia, Qatar, Spain, Kenya, Lebanon, Mauritius, Netherlands, Sweden, Turkey, Kuwait, Malta, Namibia, Romania, Switzerland, and Greece.
The products were distributed to the following US states: CA, CT, GA, IL, KY, MA, MD, MO, PA, TX, WA, and WI. The products were distributed to the following foreign countries: Australia, Brazil, Canada, China, Costa Rica, India, Japan, Mexico, The Philippines, Russia, South Korea, South Africa, Switzerland, and Uruguay.
Worldwide distribution. US nationwide, Netherlands, Mexico, Paraguay, Brazil, Argentina, Malaysia, Costa Rica, Chile, South Korea, and Canada.
PA, MA, TX, ME, UT, FL, KS, NH, KY and Foreign
Distributed US Nationwide and Puerto Rico.
Distributed to accounts in 20 states: AL, CA, CO, FL, HI, ID, IL, MA, ME, MI, NJ, NV, NY, OH, OR, PA, SC, TX, UT, and VA. Foreign distribution to United Arab Emirates, Australia, Belgium, Brazil, Canada, Germany, Spain, Finland, France, Great Britain, Hungary, Ireland, Italy, Japan, Mexico, Netherlands, New Zealand, Portugal, Singapore, and South Africa.
Worldwide Distribution - USA (nationwide) Distribution and to the states of : NJ, NY, OH, PA, and TX., and to the countries of : Canada, South Korea, Thailand, Australia and Taiwan.
Nationwide Distribution to states of: AZ, UT, WI, NJ, CT, TX, PA, VA, MN, MA, MO, FL, and CA.
US Nationwide Distribution in the states of West Virginia and Puerto Rico
US Nationwide Distribution to accounts in 21 states: AZ, CA, CO, ID, IL, KS, MA, MI, MS, NC, NY, OH, OK, PA, RI, TN, TX, UT, VA, WA, WI; and PR.
Shipped to customers nationwide and Canada.
Distributed to accounts in 7 states: AL, CA, GA, NE, NV, NY, and TX. International distribution to Japan, Korea, and Taiwan.
Worldwide Distribution - US Nationwide in the states of GA, CT, LA, MD, WY, IN, MD, FL, and France
WA, GA, SC, FL, NJ, LA, CA, TX, NV, NC, PA, MO, CO, OR, MT, MA, UT, NE, AZ, MO, NY, OH, VA, MD.
The product was distributed to the following US state: MO. The product was distributed to the following foreign countries: France, Germany, Switzerland, and Thailand.
Distributed to the states of CA, FL, NC, NE, NY, and WA.
Worldwide Distribution - US Nationwide and the country of Canada
Worldwide Distribution - US Nationwide in the states of OH, FL, NH, TX, Sweden, Canada
The products were distributed to the following US states: FL, MO, and PA.
Recalled product was distributed to retail stores in AZ, IA, ID, IL, KS, MI, UT, and WY.
Worldwide Distribution - USA (nationwide) and to the counties of : Canada and Taiwan.
Distributed to accounts in AL, AR, CA, DC, FL, IL, LA, MO, NC, PA, SC, TX, and WA.
US Nationwide Distribution in the states of AL, AZ, CA, FL, GA, IL, MA, NJ, NM, NY, TX
The products were distributed to the following US states: CA, FL, GA, IA, IL, OH, TN, and VA. The products were distributed to the following foreign countries: Canada, United Kingdom, and Malta.
Product distributed to retail stores and distributors in Alabama, Arkansas, Florida, Maine, Missouri, Nebraska, Nevada, New Mexico, New York, Ohio, Oklahoma, Texas, Utah, Washington and Wyoming.
US Nationwide Distribution in the states of: AR, AZ, CA, FL, GA, IL, IN, LA, MA, MI, MO, MS, NC, ND, NH, NJ, NV, NY, OH, PA, SC, TN, TX, VA, WA, WI, WV, and Puerto Rico.
Distributed nationwide throughout the US and the following countries - Vietnam, Dom Republic, Kuwait, Panama, Saudi, Korea, Germany, Iceland, EU, Bermuda, Australia, Jordan
FL, AR, OR, UT, PA, CA, NJ, MA,NY, MD, IL, IN,SC, TN, LA, GA.
US Distribution to the states of : California and Georgia
worldwide Distribution - US Distribution to the states of : CA, FL, MO, NC, SC, TX, and WI., and to the countries of : Argentina, China, Colombia, Germany, Japan, Netherlands, South Africa, Thailand, and Vietnam.
AK, AR, AZ, CA, CO, CT, FL, IL, MA, MN, MO, NC, NH, NJ, NY, PA, TX, VT, WA, WI, WY
Product Distributed thru our the nation.
Distributed in CA, IL, FL, MI, NH, NJ, NY, OR, and TX.

Product Description
AirLife Resuscitation, Infant, with mask, 28inch large bore tubing, pressure-relief valve Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.
AirLife Resuscitation, Infant, with mask, oxygen reservoir bag, pressure-relief valve, PEEP valve Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.
AirLife Resuscitation, Infant, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, PEEP valve Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.
AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, CO2 detector Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.
AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, Broselow Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.
AirLife Resuscitation, Infant, with mask, oxygen reservoir bag, pressure-relief valve Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.
AirLife Resuscitation, Infant, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, Broselow Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.
AirLife Resuscitation, Pediatric, with mask, oxygen reservoir bag, pressure-relief valve Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.
AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, filter Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.
AirLife Resuscitation, Broselow Hinkle Kit Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.
AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, CO2 detector, PEEP valve Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.
AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, pressure-relief valve Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.
AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, CO2 monitor Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.
AirLife Resuscitation, Pediatric, with mask, oxygen reservoir bag, pressure-relief valve, PEEP valve Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.
AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, CO2 detector, manometer Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.
AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, PEEP valve Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.
AirLife Resuscitation, Infant, with mask, 40 inch oxygen reservoir tubing, pressure-relief valve, CO2 detector, manometer Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.
AirLife Resuscitation, Adult, with mask, 28inch large bore tubing Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.
AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, manometer, PEEP valve Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.
AirLife Resuscitation, Adult, with mask, 28inch large bore tubing, pressure-relief valve Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.
AirLife Resuscitation, Replacement kit for outer shell, Broselow Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.
AirLife Resuscitation, Pediatric, with mask, 28inch large bore tubing, pressure-relief valve Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.
AirLife Resuscitation, Infant, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, manometer Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.
AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, manometer Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.
AirLife Resuscitation, Adult, with mask, 40inch oxygen reservoir tubing, PEEP valve Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.
AirLife Resuscitation, Infant, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, CO2 monitor, monometer Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.
AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, filter Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.
oxygen reservoir tubing 6/cs Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.
AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, CO2 monitor, monometer Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.
AirLife Resuscitation, Infant, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, manometer, PEEP valve Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.
AirLife Resuscitation, Pediatric, with mask, oxygen reservoir bag, manometer, pressure-relief valve, PEEP valve Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.
AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, PEEP valve Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.
AirLife Resuscitation, Adult, with mask, 40inch oxygen reservoir tubing, filter Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.
AirLife Resuscitation, Adult, with mask, oxygen reservoir bag Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.
Dimension Vista Glucose (GLU) assay; (Product Number: K1039/10445162) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
Dimension Vista Creatine Kinase MB (MBI) assay; (Product Number: K3032/10464339) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
Dimension Vista Aspartate Aminotransferase (AST) assay; (Product Number: K2014/10445148) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
Dimension Glucose (GLUC) assay (Product Number: DF40/10444973) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
Dimension Vista Ammonia (AMM) assay (Product Number: K3119/10711992) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
Syva Emit 2000 Tacrolimus Assay (Product Number: 8R019UL/10445397) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
Dimension Vista Thyroxine (T4) assay; (Product Number: K6065/10445101) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
Dimension Ammonia (AMM) assay; (Product Number: DF119/10711991) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
Dimension Alanine Aminotransferase (ALTI) assay; (Product Number: DF143/10475530) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
Dimension Aspartate Aminotransferase (AST) assay (Product Number: DF41A/10444959) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
Dimension Vista Alanine Aminotransferase (ALTI) assay; (Product Number: K2143/10635565) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
ADVIA Ammonia (AMM) chemistry assay, an in vitro diagnostic device intended to quantitatively measure Ammonia levels in human plasma (heparin or EDTA). Product Number: 10286035 (Mfr: Randox Laboratories)
ADVIA Salicylate (SAL) reagent chemistry assay; use in the quantitative determination of salicylate in human serum and plasma (lithium heparin). Product Number: 10327382 (Mfr: Sekisui Diagnostics)
Syva Emit 2000 Sirolimus Assay (Product Number: 8S019UL/10445401) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
Dimension Thyroxine (T4) assay (Product Number: DF65/10444908) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
Dimension Creatine Kinase MB (MBI) assay (Product Number: DF32/10464510) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
ADVIA Alanine Aminotransferase (ALT) reagent chemistry assays; ALT intended to measure the activity of the enzyme alanine amino transferase (ALT) (also known as a serum glutamic pyruvic transaminase or SGPT) in serum and plasma. (Product Numbers: 10318168, 10309500), ALT P5P (Part Numbers: 10318168/10326245, 10309500/10315181), and ALT Concentrated (Part Numbers: 10283341, 10283341, 10283342); (Mfr: Randox Laboratories)
ReNew Dolphin Nose Disposable Dissector Tip, Catalog Number: 3312, UDI: 00811099011989 The ReNew single patient use disposable tips are to be used with the ReNew Laparoscopic Hand Pieces and they are indicated for cutting, grasping, dissecting and coagulation of tissue in endoscopic and laparoscopic surgical procedures.
ReNew Endocut Scissor Disposable Tip, Catalog Number: 3142, UDI: 00811099012115 The ReNew single patient use disposable tips are to be used with the ReNew Laparoscopic Hand Pieces and they are indicated for cutting, grasping, dissecting and coagulation of tissue in endoscopic and laparoscopic surgical procedures.
ARCHITECT DHEA-S Reagent Product Usage: It is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of dehydroepiandrosterone sulfate (DHEA-S) in human serum and plasma on the ARCHITECT iSystem.
LATARJET EXPERIENCE Sharp Curved Ostetome Product Usage: The Latarjet EXPERIENCE Instability Shoulder Set is intended to provide to the orthopedic surgeon with a means of bone fixation and to assist in the management of reconstructive surgeries.
ACUSON SC2000 Ultrasound System. The firm name on the label is Siemens Medical Solutions USA, Inc., Buffalo Grove, IL.
BECKMAN COULTER iChemVELOCITY, Urine Chemistry System, Catalog Numbers: 800-3530, 800-7167, 800-7719, 800-7720, 800- 7106, 800-3049, 800-3050, 800-3079, 800-3080, 800-7190, 800-7713, 800-7714, 800-7715, 700- 7176-001, 700-7177-001 Product Usage: The iChemVELOCITY automated urine chemistry system is an in vitro diagnostic device used to automate the urine chemistry analysis profile using iChemVELOCITY Urine Chemistry Strips. The iChemVELOCITY can be used as a stand-alone system, as well as in an iQ200 Series system, a configuration given the proprietary name iRICELL as it is designed to be hardware and software compatible with iQ200 Series systems. It produces quantitative results for specific gravity, semi- quantitative results for glucose, blood, leukocyte esterade, bilirubin, urobilinogen, pH, protein, ketones, and ascorbic acid; and qualitative results for nitrites, color, and clarity. iChemVELOCITY strips are intended for use only with the iChemVELOCITY analyzer. In particular they are not intended for visual reading. The iChemVELOCITY is not intended to be used as a Point of Care (POC) analyzer. The measurements are used to aid in the diagnosis of metabolic disorders, kidney function anomalies, urinary tract infections, and liver finction. Tests performed using the iChemVELOCITY are intended for clinical laboratory use and in vitro diagnostic use only.
RESTORIS MCK TIBIAL BASEPLATE-RM/LL used in unicompartmental knee arthroplasty and knee replacements.
Capio RP; Model #M0068321010. Intended for use in general suturing applications during open surgery to assist in the placement of suture material in tissues at the operative site.
Capio SLIM Box 5, Model #M0068318261; Intended for use in general suturing applications during open surgery to assist in the placement of suture material in tissues at the operative site.
Capio CL; Model #M0068311350. Indicated for the placement of suture in a variety of Transvaginal procedures.
Capio Standard Box 4 (Capio PC); Model #M0068312321. Intended for use in general suturing applications during open or endoscopic surgery to assist in the placement of suture material in tissues at the operative site.
Uphold Vaginal Support System; Model #M0068317080. Indicated for tissue reinforcement in women with pelvic organ prolapse.
Posterior LITE w/ Capio SLIM; Model #M0068318150. Indicated for tissue reinforcement in women with pelvic organ prolapse.
Capio Open Access Box 4 (Capio OPC); Model #M0068311251. Intended for use in general suturing applications during open or endoscopic surgery to assist in the placement of suture material in tissues at the operative site.
PFR Kit- Pinnacle, Posterior; Model #M0068317100. Indicated for tissue reinforcement in women with pelvic organ prolapse.
PFR Kit- Pinnacle, Anterior Apical; Model #M0068317100. Indicated for tissue reinforcement in women with pelvic organ prolapse.
Capio SLIM Suture Capturing Device, Model #M0068318250. Intended for use in general suturing applications during open surgery to assist in the placement of suture material in tissues at the operative site.
Uphold LITE w/ Capio SLIM; Model #M0068318170. Indicated for tissue reinforcement in women with pelvic organ prolapse.
MicroVue BAP EIA, Model 8012, provides a quantitative measure of bone-specific alkaline phosphatase (BAP) activity in serum.
FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2), Laboratory Automation System
Medtronic Prestige LP(TM) Cervical Disc System with Streamlined Instruments, DRILL GUIDES: a) REF 6975205, 5mm b) REF 6975206, 6mm c) REF 6975207, 7mm Product Usage: The PRESTIGE LP reusable instruments are intended for the surgical implantation of the PRESTIGE LP Cervical Disc. Medtronic reusable instruments must be sterilized prior to initial use and must be cleaned and sterilized prior to each re-use.
Gentle Threads, Interference Screw; Model No. 905604, for soft tissue reattachment procedures in the ankle/foot and knee.
Gentle Threads, Interference Screw; Model No. 905605, for soft tissue reattachment procedures in the ankle/foot and knee.
Gentle Threads, Interference Screw; Model No. 905617, for soft tissue reattachment procedures in the ankle/foot and knee.
Gentle Threads, Interference Screw; Model No. 905608, for soft tissue reattachment procedures in the ankle/foot and knee.
Gentle Threads, Interference Screw; Model No. 905607, for soft tissue reattachment procedures in the ankle/foot and knee.
Gentle Threads, Interference Screw; Model No. 905615, for soft tissue reattachment procedures in the ankle/foot and knee.
Jasper Vektor, Class II Correction Appliance, Part No. 610-527R used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.
Jasper Vektor, Class II Correction Appliance, Part No. 610-536 used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.
Jasper Vektor, Class II Correction Appliance, Part No. 610-536L used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.
Jasper Vektor, Class II Correction Appliance, Part No. 610-533 used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.
Jasper Vektor, Class II Correction Appliance, Part No. 610-533R used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.
Jasper Vektor, Class II Correction Appliance, Part No. 610-530 used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.
Jasper Vektor, Class II Correction Appliance, Part No. 610-533Lused for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.
Jasper Vektor, Class II Correction Appliance, Part No. 610-500 used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.
Jasper Vektor, Class II Correction Appliance, Part No. 610-527L used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.
Jasper Vektor, Class II Correction Appliance, Part No. 610-530L used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.
Jasper Vektor, Class II Correction Appliance, Part No. 610-530R used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.
Jasper Vektor, Class II Correction Appliance, Part No. 610-527 used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.
Jasper Vektor, Class II Correction Appliance, Part No. 610-536R used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.
Syngo.plaza software VB10A model numbers: 10863171, 10863172, 10863173 Syngo.Plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning. Syngo.plaza also supports storage and archiving of DICOM Structured reports. In a comprehensive imaging syngo.plaza integrates Hospital/Radiology Information Systems (HIS/RIS) to enable customer specific workflows. Syngo.plaza optionally uses a variety of advanced postprocessing applications.
Syngo.plaza software Syngo.Plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning. Syngo.plaza also supports storage and archiving of DICOM Structured reports. In a comprehensive imaging syngo.plaza integrates Hospital/Radiology Information Systems (HIS/RIS) to enable customer specific workflows. Syngo.plaza optionally uses a variety of advanced postprocessing applications.
Cosentyx 150 mg/mL PFS 300 mg Dose NDC 00078-0639-98, 28 days supply
Revlimid 15 mg oral cap NDC 59572-0415-21 28 days supply
Boost VHC Oral Liquid VAN #27 NDC 43900-0182-15 27 days supply
Praluent 75 mg Pen (2 pens/Pkg) NDC 00024-5901-02 28 days supply
Creon DR 24,000 Units Capsule #250 NDC 00032-1224-07 30 days supply
Pulmicort Respules 0.5 mg/2mL s, 30 days supply, NDC 00186-1989-04
Revlimid 25 mg oral cap NDC 59572-0425-21 28 days supply
Revlimid 10 mg oral cap NDC 59572-0410-28 28 days supply
Orkambi 100 mg/125 mg Tablets #112 NDC 51167-0700-02 28 days supply.
Tecfidera 240 mg capsule NDC 64406-0006-02 30 days supply
Polyethylene Glycol 3350, powder, for solution 527g BRE, Rx Only, 28 days supply, NDC 51991-0457-57
Pulmozyme 1 mg/mL Inh. Soln. #30 NDC 50242-0100-40 30 days supply.
Bethkis 300 mg/4 mL Ampule #56 NDC 10122-0820-56 56 days supply
Pediasure Liq. Vanilla G+G (CAN) #24 24 days supply, NDC 70074-0558-98
Stelara 90 mg/MI PFS NDC 57894-0061-03 84 days supply
Xalkori 250 mg cap NDC 00069-8140-20 30 days supply
Letrozole 2.5 mg tab NDC 51991-0759-33 30 days supply
Avonex 30 mcg/0.5 mL PFS Kit NDC 59627-0222-05 28 days supply
Sprycel 80 mg tablet NDC 00003-0855-22 30 days supply
Altera Handset NDC 83490-0678-05 56 days supply
Lupron Depot 22.5 mg 3 month Kit NDC 00074-3346-03 84 days supply
Cayston 75 mg Inh. Soln. SDV NDC 61958-0901-01 56 days supply
Repatha 140 mg/mL Sureclick AI 2-pk NDC 55513-0760-02 28 days supply
Sodium Chloride 3% Inh. 4 mL NEP #30 NDC 00487-9003-60 30 days supply.
Revlimid 20 mg oral cap NDC 59572-0420-21 28 days supply
OPDIVO 40 mg/4 mL SDV NDC 00003-3772-11 28 days supply
Ondansetron 8 mg tablet NDC 57237-0076-30 28 days supply
Temozolomide 250 mg NDC 43975-0257-05 28 days supply
Azithromycin 250 mg tablet #18 TEV NDC 50111-0787-66 28 days supply
Tasigna Capsules 150 mg NDC 00078-0592-87 28 days supply
Revlimid 5 mg oral cap NDC 59572-0405-28 28 days supply
Perjeta 420 mg/14 mL SDV Vials 50242-0145-01 21 days supply
Imatinib Mesylate Tablet 400 mg NDC 60505-2901-03 30 days supply
Promacta 50 mg tablet NDC 00078-0686-15 30 days supply
Sutent 50 mg capsules x28 NDC 00069-0550-38 42 days supply
Copaxone 40 mg Injection (12) NDC 68546-0325-12 28 days supply.
Temozolomide 20 mg NDC 43975-0253-05 28 days supply
Orkambi 200 mg/125 mg Tablets #112 NDC 51167-0809-01 28 days supply.
Bendeka 25 mg/mL 4 mL MDVPF NDC 63459-0348-04 28 days supply
Pomalyst 3 mg capsule NDC 59572-0503-21 28 days supply
Copaxone 20 mg Injection PFS (30) NDC 68546-0317-30 30 days supply.
Albuterol 0.083% Inh Sol. 30 days supply, Rx Only, 39183, NDC 76204-0200-60, 30
Cyclophosphamide 50 mg cap NDC 00054-0383-25 28 days supply
Cimzia 200 mg/mL PFS Kit #2 NDC 50474-0710-79 28 days supply.
Capecitabine 500 mg Tablet NDC 00378-2512-78 28 days supply and 21 days supply
Dexamethasone 4 mg tablet NDC 49884-0087-01 28 days supply
Kalydeco 150 mg tablet blister, 28 days supply, Rx Only, 39183, NDC 51167-0200-01
Capecitabine 150 mg Tablet NDC 00378-2511-91 28 days supply
Sprycel 100 mg tablet NDC 00003-0852-22 30 days supply
Dupixent 300 mg/2 mL PFS #2 w/ NS NDC 00024-5914-01 28 days supply
Gleevec 100 mg tablet NDC 00078-0401-34 30 days supply
MVW Complete Softgels NDC 58204-0004-00 30 days supply; MVW Complete Chew Vitamin Grape NDC 58204-0004-15 30 days supply.
Sutent 37.5 mg capsules x28 NDC 00069-0830-38 28 days supply
Kitabis Pak 300 mg/5 mL Soln PARI #56 NDC 24492-0850-56 56 days supply
Botox 100 Units Vial NDC 00023-1145-01 90 days supply.
Prolia 60 mg/1 mL PF syringe NDC 55513-0710-01 180 days supply.
Zarxio 300 mcg/0.5 mL PFS NDC 14 days supply
Glatiramer Acetate 40 mg/mL NDC 00378-6961-12 28 days supply
Enbrel PFS 50 mg/mL Inj #4 NDC 58406-0435-04 28 days supply;
Ibrance 125 mg cap NDC 00069-0189-21 28 days supply
Kisqali 600 Dose 63 tablet 200 mg NDC 00078-0874-63 28 days supply
Otezla 30 mg tablet NDC 59572-0631-06 30 days supply;
Taltz 80 mg/mL Pen 1-pk NDC 00002-1445-11 28 days supply
Humira Pen Sub-q Kit a.) 40 mg/0.8 mL (NDC 00074-4339-02); Humira Pen Psor Kit b.) 40 mg/0.8 mL (NDC 00074-4339-07) 28 day supply, Rx Only,
Xtandi 40 mg capsule NDC 00469-0125-99 30 days supply
Xolair 150 mg SDV NDC 50242-0040-62 28 days
Transonic ADT1018 Flow QC Clear Advantage Tubing, Catalog No. ADT1018, ADT1018-40 The device is indicated for use as part of an extracorporeal blood circuit for hemodialysis when a monitor will be used to make access flow, recirculation, and/or cardiac output measurements during the patient s hemodialysis treatment.
PICC Kit, Product Code: AMS-7063-1 Convenience kit for the insertion of PICCs into the vascular system.
PICC Insertion Tray, Product Code: AMS-7192CS-3 Convenience kit for the insertion of PICCs into the vascular system.
Maximum Barrier Tray, Product Code: MCITX-1 Convenience kit for the insertion of PICCs into the vascular system.
PICC Tray, Product Code: AMS-9093CP Convenience kit for the insertion of PICCs into the vascular system.
Maximum Barrier Tray, Product Code: AMS-9018CP Convenience kit for the insertion of PICCs into the vascular system.
PICC Insertion Tray, Product Code: AMS-7192CS-4 Convenience kit for the insertion of PICCs into the vascular system.
Neonatal PICC Tray, Product Code: AMS-8010CP-1 Convenience kit for the insertion of PICCs into the vascular system.
Maximum Barrier Insertion Tray, Product Code: AMS-9152CP Convenience kit for the insertion of PICCs into the vascular system.
Thumper Cardiopulmonary Resuscitator, Model 1007CCV, Catalog No. 15370 Product Usage: The device is used to perform Cardiopulmonary Resuscitation (CRP) on adult patients and only adult patients in cases of clinical death as defined by a lack of spontaneous breathing and pulse.
Manuka Honey Wound Gel Catalogue No: 716597 Product Usage: Helps maintain a moist wound environment which has shown to be conducive to wound healing Ideal for minor scalds and burns, minor cuts, lacerations and minor abrasions
Lipase, Catalog number: LI3837; GTIN: 05055273204230 and Catalog number: LI8361; GTIN: 05055273214284 Product Usage: For Professional Use for the quantitative in vitro determination of Lipase in human serum and plasma. Lipase measurements are used in the diagnosis and treatment of diseases of the pancreas such as acute pancreatitis and obstruction of the pancreatic duct.
Fabius GS Premium, anesthesia machine, catalog no. 8607000 Product Usage: The products are inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be used with O2, N2O, and AIR supplied by a medical gas pipeline system or by externally mounted gas cylinders. Fabius series anesthesia machines are equipped with an electrically driven and electronically controlled ventilator and monitors for airway pressure (P), volume (V), and inspiratory oxygen concentration (FiO2).
Fabius Tiro M, anesthesia machine, catalog no. 8608400 Product Usage: The products are inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be used with O2, N2O, and AIR supplied by a medical gas pipeline system or by externally mounted gas cylinders. Fabius series anesthesia machines are equipped with an electrically driven and electronically controlled ventilator and monitors for airway pressure (P), volume (V), and inspiratory oxygen concentration (FiO2).
Fabius Tiro, anesthesia machine, catalog no. 8606000 Product Usage: The products are inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be used with O2, N2O, and AIR supplied by a medical gas pipeline system or by externally mounted gas cylinders. Fabius series anesthesia machines are equipped with an electrically driven and electronically controlled ventilator and monitors for airway pressure (P), volume (V), and inspiratory oxygen concentration (FiO2).
Fabius MRI, anesthesia machine, catalog no. 8607300 Product Usage: The products are inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be used with O2, N2O, and AIR supplied by a medical gas pipeline system or by externally mounted gas cylinders. Fabius series anesthesia machines are equipped with an electrically driven and electronically controlled ventilator and monitors for airway pressure (P), volume (V), and inspiratory oxygen concentration (FiO2). This device can also be used in MRI scanner rooms with magnets 1.5 tesla and 3 tesla at a fringe field strength of 40 mtesla or less.
Energique, Dietary Supplement, Enervimin CNCR Focus, Dist. by Energique Inc.. Woodbine, IA 51579
Energique, Herbal Supplement, Octocom,; Dist. by Energique, Inc. Woodbine, IA 51579
Peaceful Mountain -Stomach Rescue - Dietary supplement - Elemental silver (45 ppm) 2.7 mg; Dist. by Peaceful Mountain, Inc. Woodbine, IA 51579
Peaceful Mountain, Nasal Rescue, Dietary Supplement, Natural Sinus Support, Dist. by Peaceful Mountain, Inc. Woodbine, IA 51579
Connecting Tube - Female to Male Luer Lock, HPCT8.8-60-M-FM-BNS Product Usage: The connecting tube is intended to be a conduit between a fluid reservoir and a vascular catheter in the patient. The connecting tube may be used during angiographic procedures to connect radiographic contrast power injector to a vascular catheter, arterial pressure monitoring, and fluid infusion.
Connecting Tube - Female to Male Luer Lock, HPCT8.8-80-M-FM Product Usage: The connecting tube is intended to be a conduit between a fluid reservoir and a vascular catheter in the patient. The connecting tube may be used during angiographic procedures to connect radiographic contrast power injector to a vascular catheter, arterial pressure monitoring, and fluid infusion.
Connecting Tube - Female to Male Luer Lock, HPCT8.8-100-M-FM Product Usage: The connecting tube is intended to be a conduit between a fluid reservoir and a vascular catheter in the patient. The connecting tube may be used during angiographic procedures to connect radiographic contrast power injector to a vascular catheter, arterial pressure monitoring, and fluid infusion.
Connecting Tube - Female to Male Luer Lock, HPCT8.8-60-M-FM Product Usage: The connecting tube is intended to be a conduit between a fluid reservoir and a vascular catheter in the patient. The connecting tube may be used during angiographic procedures to connect radiographic contrast power injector to a vascular catheter, arterial pressure monitoring, and fluid infusion.
Connecting Tube - Female to Male Luer Lock, HPCT8.8-30-M-FM Product Usage: The connecting tube is intended to be a conduit between a fluid reservoir and a vascular catheter in the patient. The connecting tube may be used during angiographic procedures to connect radiographic contrast power injector to a vascular catheter, arterial pressure monitoring, and fluid infusion.
Connecting Tube - Female to Male Luer Lock, HPCT8.8-120-M-FM Product Usage: The connecting tube is intended to be a conduit between a fluid reservoir and a vascular catheter in the patient. The connecting tube may be used during angiographic procedures to connect radiographic contrast power injector to a vascular catheter, arterial pressure monitoring, and fluid infusion.
Medtronic ZEVO(TM) Anterior Cervical Plate System SLOT SCREW, REF 7710015, Size 4.5mm x 15mm Product Appliance, fixation, spinal intervertebral body
ZYMUTEST HIA IgGAM; REF Number: RK040D; UDI: 03663537018770 a qualitative screening assay intended for the global detection of heparin- dependent antibodies, whether the isotype is: IgG, IgM and IgA, in human plasma, by clinical laboratories.
ZYMUTEST HIA MonoStria qualitative screening assay intended for the global detection of heparin-dependent antibodies, whether the isotype is: IgG, IgM and IgA, in human plasma, by clinical laboratories. p IgGAM; REF Number: RK041D; UDI: 03663537046810
ZYMUTEST HIA MonoStrip IgG; REF Number: RK041A; UDI: 03663537046803 a qualitative assay intended for the detection of heparin-dependent antibodies of the IgG isotype, in human plasma, by clinical laboratories. It is intended for in vitro diagnostic use.
Third Eye Kratom Red in 300 capsule plastic bottles. Manufactured for Raw Form Organics, Las Vegas, NV 89118 by Triangle Pharmanaturals, LLC, Las Vegas, NV 89119
Lifted Kratom Red Maeng Da in 45 gram powder, 150 capsule and 300 capsule plastic bottles.. Manufactured for Raw Form Organics, Las Vegas, NV 89118 by Triangle Pharmanaturals, LLC, Las Vegas, NV 89119
Chameleon Kratom Formula 27 in 60 capsule plastic bottles; Manufactured for Raw Form Organics, Las Vegas, NV 89118 by Triangle Pharmanaturals, LLC, Las Vegas, NV 89119
Molecule Kratom Red Maeng Da in 20 capsule, 80 capsule, 45 gram, and 250 gram plastic bottles; Manufactured for Raw Form Organics, Las Vegas, NV 89118 by Triangle Pharmanaturals, LLC, Las Vegas, NV 89119
Live Well Kratom Red Maeng Da in 150 capsule and 300 capsule plastic bottles. Manufactured for Raw Form Organics, Las Vegas, NV 89118 by Triangle Pharmanaturals, LLC, Las Vegas, NV 89119
Raw Form Organics Maeng Da Kratom Amethyst Gold in 150 capsule and 300 capsule plastic bottles; Manufactured for Raw Form Organics, Las Vegas, NV 89118 by Triangle Pharmanaturals, LLC, Las Vegas, NV 89119
Molecule Kratom Red Malay in 20 capsule, 80 capsule, 45 gram, and 250 gram plastic bottles; Manufactured for Raw Form Organics, Las Vegas, NV 89118 by Triangle Pharmanaturals, LLC, Las Vegas, NV 89119
Molecule Kratom Super Green Malay in 20 capsule, 80 capsule, 45 gram, and 250 gram plastic bottles; Manufactured for Raw Form Organics, Las Vegas, NV 89118 by Triangle Pharmanaturals, LLC, Las Vegas, NV 89119
Live Well Kratom Green Maeng Da in 150 capsule and 300 capsule plastic bottles. Manufactured for Raw Form Organics, Las Vegas, NV 89118 by Triangle Pharmanaturals, LLC, Las Vegas, NV 89119
Lifted Kratom Green Maeng Da in 45 gram powder, 150 capsule and 300 capsule plastic bottles. Manufactured for Raw Form Organics, Las Vegas, NV 89118 by Triangle Pharmanaturals, LLC, Las Vegas, NV 89119
Molecule Kratom Gold Bali in 20 capsule, 80 capsule, 45 gram, and 250 gram plastic bottles; Manufactured for Raw Form Organics, Las Vegas, NV 89118 by Triangle Pharmanaturals, LLC, Las Vegas, NV 89119
Third Eye Kratom White in 300 capsule plastic bottles; Manufactured for Raw Form Organics, Las Vegas, NV 89118 by Triangle Pharmanaturals, LLC, Las Vegas, NV 89119
Lifted Kratom White Maeng Da in 45 gram powder, 150 capsule and 300 capsule plastic bottles. Manufactured for Raw Form Organics, Las Vegas, NV 89118 by Triangle Pharmanaturals, LLC, Las Vegas, NV 89119
Molecule Kratom White Maeng Da in 20 capsule, 80 capsule, 45 gram powder, and 250 gram powder plastic bottles; Manufactured for Raw Form Organics, Las Vegas, NV 89118 by Triangle Pharmanaturals, LLC, Las Vegas, NV 89119
Third Eye Kratom Bali in 300 capsule plastic bottles. Manufactured for Raw Form Organics, Las Vegas, NV 89118 by Triangle Pharmanaturals, LLC, Las Vegas, NV 89119
Raw Form Organics Maeng Da Kratom Ruby Red; R150 capsule and 300 capsule plastic bottles; Manufactured for Raw Form Organics, Las Vegas, NV 89118 by Triangle Pharmanaturals, LLC, Las Vegas, NV 89119
Raw Form Organics Maeng Da Kratom Emerald Green; 150 capsule and 300 capsule plastic bottles; Manufactured for Raw Form Organics, Las Vegas, NV 89118 by Triangle Pharmanaturals, LLC, Las Vegas, NV 89119
Raw Form Organics Maeng Da Kratom Ivory White; 150 capsule and 300 capsule plastic bottles; Manufactured for Raw Form Organics, Las Vegas, NV 89118 by Triangle Pharmanaturals, LLC, Las Vegas, NV 89119
Molecule Kratom Green Maeng Da in 20 capsule, 80 capsule, 45 gram, and 250 gram plastic bottles; Manufactured for Raw Form Organics, Las Vegas, NV 89118 by Triangle Pharmanaturals, LLC, Las Vegas, NV 89119
Naturally Kratom Bali Gold in 6 capsule bags. Manufactured for Raw Form Organics, Las Vegas, NV 89118 by Triangle Pharmanaturals, LLC, Las Vegas, NV 89119
Naturally Kratom White Maeng Da in 6 capsule bags. Manufactured for Raw Form Organics, Las Vegas, NV 89118 by Triangle Pharmanaturals, LLC, Las Vegas, NV 89119
Molecule Kratom White Borneo in 20 capsule, 80 capsule, 45 gram powder, and 250 gram powder plastic bottles; Manufactured for Raw Form Organics, Las Vegas, NV 89118 by Triangle Pharmanaturals, LLC, Las Vegas, NV 89119
Chameleon Kratom Formula 51 in 60 capsule plastic bottles; Manufactured for Raw Form Organics, Las Vegas, NV 89118 by Triangle Pharmanaturals, LLC, Las Vegas, NV 89119
Lifted Kratom Gold Bali in 45 gram powder, 150 capsule and 300 capsule plastic bottles. Manufactured for Raw Form Organics, Las Vegas, NV 89118 by Triangle Pharmanaturals, LLC, Las Vegas, NV 89119
Naturally Kratom Green Malay in 6 capsule bags.. Manufactured for Raw Form Organics, Las Vegas, NV 89118 by Triangle Pharmanaturals, LLC, Las Vegas, NV 89119
Naturally Kratom Red Malay in 6 capsule bags. Manufactured for Raw Form Organics, Las Vegas, NV 89118 by Triangle Pharmanaturals, LLC, Las Vegas, NV 89119
CARDIOHELP Gas Bottle Holder HKH 8880, Product Code/Part Number 70105.0901 Product Usage: The Cardiohelp Gas Bottle (or Cylinder) Holder HKH 8880 is an accessory for the CARDIOHELP System and required for inter-hospital patient transport in aircraft and road vehicles (mobile intensive care units and ambulances). Inter-hospital patient transport is transport of the patient between clinics, where the clinical environment is left (e.g., transport in vehicles such as ambulances or aircraft). The gas cylinder holder serves to hold an oxygen cylinder in aircraft.
Hemodynamic monitoring system (HMS), comprised of a Patient Interface Module (Part Number 58401-000 and a User Interface Module (Part Number 58403-000). Intended for patients for whom the monitoring of continuous cardiac output is indicated for diagnostic and prognostic evaluation by a clinician in the hospital.
Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 35700BAXRP Product Usage: The Baxter Sigma Spectrum Infusion Pump with master Drug Library is intended to be used for the controlled administration of fluids. These fluids may includes pharmaceutical drugs, blood, blood products and mixture if required patient therapy. The intended routes of administration consist of the following clinically accepted routes: intravenous, arterial, subcutaneous, intrathecal, epidural or irrigation of fluids. Spectrum infusion pump is intended to be used in conjunction with legally marketed intravenous administration sets and medications provided by user. The Spectrum and Spectrum with MAster Drug Library is intended to reduce operator interaction through automated programming thereby helping to reduce errors associated with complex device programming.
Baxter Sigma Spectrum Infusion Pump with master Drug Library (Version 6) 35700BAX Product Usage: The Baxter Sigma Spectrum Infusion Pump with master Drug Library is intended to be used for the controlled administration of fluids. These fluids may includes pharmaceutical drugs, blood, blood products and mixture if required patient therapy. The intended routes of administration consist of the following clinically accepted routes: intravenous, arterial, subcutaneous, intrathecal, epidural or irrigation of fluids. Spectrum infusion pump is intended to be used in conjunction with legally marketed intravenous administration sets and medications provided by user. The Spectrum and Spectrum with MAster Drug Library is intended to reduce operator interaction through automated programming thereby helping to reduce errors associated with complex device programming.
Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 35700BAXR Product Usage: The Baxter Sigma Spectrum Infusion Pump with master Drug Library is intended to be used for the controlled administration of fluids. These fluids may includes pharmaceutical drugs, blood, blood products and mixture if required patient therapy. The intended routes of administration consist of the following clinically accepted routes: intravenous, arterial, subcutaneous, intrathecal, epidural or irrigation of fluids. Spectrum infusion pump is intended to be used in conjunction with legally marketed intravenous administration sets and medications provided by user. The Spectrum and Spectrum with MAster Drug Library is intended to reduce operator interaction through automated programming thereby helping to reduce errors associated with complex device programming.
Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 35700BAXRE Product Usage: The Baxter Sigma Spectrum Infusion Pump with master Drug Library is intended to be used for the controlled administration of fluids. These fluids may includes pharmaceutical drugs, blood, blood products and mixture if required patient therapy. The intended routes of administration consist of the following clinically accepted routes: intravenous, arterial, subcutaneous, intrathecal, epidural or irrigation of fluids. Spectrum infusion pump is intended to be used in conjunction with legally marketed intravenous administration sets and medications provided by user. The Spectrum and Spectrum with MAster Drug Library is intended to reduce operator interaction through automated programming thereby helping to reduce errors associated with complex device programming.
Baxter Sigma Spectrum Infusion Pump with master Drug Library (Version 6) 35700BAXL Product Usage: The Baxter Sigma Spectrum Infusion Pump with master Drug Library is intended to be used for the controlled administration of fluids. These fluids may includes pharmaceutical drugs, blood, blood products and mixture if required patient therapy. The intended routes of administration consist of the following clinically accepted routes: intravenous, arterial, subcutaneous, intrathecal, epidural or irrigation of fluids. Spectrum infusion pump is intended to be used in conjunction with legally marketed intravenous administration sets and medications provided by user. The Spectrum and Spectrum with MAster Drug Library is intended to reduce operator interaction through automated programming thereby helping to reduce errors associated with complex device programming.
IMRIS IMRI 1.5T AND 3T S System Product Usage: The IMRIS intraoperative MRI systems are traditional MRI systems that have been suspended on an overhead rail system. and is designated to operative inside an RF shielded room to facilitate intraoperative and multi room use.
ATTUNE Revision CRS Femoral LT SZ 5 Cemented, Catalog No. 150440105, Femoral Revision Implant, Knee
ATTUNE Revision CRS Femoral RT SZ 5 Cemented, Catalog No. 150440205, Femoral Revision Implant, Knee
POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex Silk, Polyurethane Catheter with Open Suture Holes, REF 5676301
POWERPORT ClearVUE isp Implantable Port With Smooth Septum and Attachable 8F Polyurethane Open-Ended Single-Lumen Venous Catheter Custom Kit, REF CP00004
POWERPORT(R) ClearVUE(R) isp with Smooth Septum, 6F ChronoFlex(TM), Polyurethane Catheter, REF 1666362
POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter, REF 1678300
POWERPORT ClearVUE Slim Implantable Port with Smooth Septum and Attachable 8F Polyurethane Open-Ended Single-Lumen Venous Catheter Custom Kit, REF CP00005
POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex, Polyurethane Catheter with Open Suture Holes, REF 1676301
POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex Silk, Polyurethane Catheter, REF 5676300
POWERPORT ClearVUE isp with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter, REF 5668362
POWERPORT ClearVUE isp with Smooth Septum, 6F ChronoFlex, Polyurethane Catheter, REF 5666362
POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter with open suture holes, REF 5678301
POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter with Open Suture Holes, REF 1678301
POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter with open suture holes, REF 5678300
POWERPORT ClearVUE isp with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter, REF 1668362
POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex Silk, Polyurethane Catheter, REF 1676300
Retractor f/Sciatic Nerve; Part number: 03.100.013; UDI: 10886982070623
Retractor f/Sciatic Nerve Long; Part number: 03.100.014; UDI: 10886982070630
Dragon Maeng Da Kratom Powder: 60 g and 150 g bottle. Dragon Maeng Da Kratom: 200-, 80-, and 40-ct x 500mg capsules in bottles.
Dragon Bali Kratom Powder: 60g Bottle. Dragon Bali Kratom Capsules in bottles:200 ct 500mg, 80 ct x 500, 40 ct x 500mg and 20 ct x 500 mg pouch.
Dragon Malaysian Kratom Powder: 150 g bottle. Dragon Malaysian Kratom: 200-, 80-, and 40-ct x 500mg capsules in bottles. Dragon Malaysian Kratom: 20-ct x 500 mg capsules in pouches.
Dragon Ultra Ehanced Indo Extract 4-ct x 500 mg capsules in pouches.
Ondamed Biofeedback Device, Model No. 001-00-0101 The product is a battery powered biofeedback device that is indicated for relaxation training and muscle re-education and prescription use.
BEQ-TOP 40700 HUNTINGTON, Catalog No. 701062899
BEQ-TOP 22301, Custom Tubing Kit, Catalog No. 701049513
BEQ-TOP 22300, Custom Tubing Kit, Catalog No. 701049504
NICU ECC Pack BEQ-TOP 39202, Custom Tubing Kit, Catalog No. 701067313R01
BEQ-TOP 5210 ECC Set - Respiratory, Custom Tubing Kit, Catalog No. 701055604R01
BEQ-TOP 50900 Custom ECC Pack-Neonatal 1/4, Custom Tubing Kit, Catalog No. 709000069R02
BEQ-TOP 38900 ECC PACK, Custom Tubing Kit, Catalog No. 701056368
BEQ-TOP 41201 ECC 3/8 PUMP PAC, Custom Tubing Kit, Catalog No. 701064867
BEQ-TOP 50903 Custom ECC Pack-Pedriatric , Custom Tubing Kit, Catalog No. 709000078
BEQ-TOP 24500 ADULT ECC, Custom Tubing Kit, Catalog No. 701050253
Better Bladder Pack, Custom Tubing Kit, Catalog No. 709000370
BO-TOP 20700 SMALL PATIENT 3/8, Custom Tubing Kit, Catalog No. 701050966
BO-TOP 20705 SMALL PATIENT 1/4, Catalog No. 701053486
BEQ-T 9410 Lurie Chldns Small 1/4, Custom Tubing Kit, Catalog No. 709000430
BEQ-TOP 24202 ADULT ECC, Catalog No. 701054295
BEQ-TOP 49101 Childrens Large ECC Pack, Custom Tubing Kit, Catalog No. 701067069R01
BEQ-TOP 22702 ECC W/HMOD 30000, Catalog No. 701051179
PACK, Custom Tubing Pack with Bioline Coating, Catalog No. 701053845
BEQ-TOP 8504 1/4X1/4 PACK W/QP, Custom Tubing Kit, Catalog No. 701066949R02
BEQ-T 25502 1/4 Better Bladder , Custom Tubing Kit, Catalog No. 709000434
BEQ-TOP 27610 ECC PACK 3/8, Custom Tubing Kit, Catalog No. 701065622
BEQ-TOP 25500 ECC 3/8 w/QiD, Custom Tubing Kit, Catalog No. 701052461
BO-TOP 13901 RAPID RESPONSE, Custom Tubing Kit, Catalog No. 701054874
Adult ECC Pack BEQ-TOP 22300, Catalog No. 701049504
Small Patient ECC Pack BEQ-TOP 22301, Catalog No. 701049513
ECC Small - Respiratory BEQ-TOP 5210, Custom Tubing Kit, Catalog No. 701055604
Smoked Salmon Spread 5 lb. bulk units; Simply Superior Smoked Salmon Spread 5 oz units; and Morey s Smoked Salmon Spread 6 oz units; Deli Cups, Deli Tubs
Whole Wheat Chocolate Animal Cookies; 5 oz. pouch, 5 lb. Corporate bags UPC: 8 58950 00508 6 Ingredients: Whole Wheat Flour, Unbleached Enriched Wheat Flour (niacin, reduced iron, thiamine mononitrate, riboflavin, folic acid). soluble Corn Prebiotic Fiber, Granulated sugar, Expeller Expressed Canola Oil, cocoa powder, Unsweetened Chocolate, natural Flavor, Baking Soda, Salt, Pure Vanilla Extract. Contains: Wheat Packed in a facility that also processes peanuts, tree nuts, milk, wheat, egg and soy. distributed by NatureBox Redwood City, CA Vanilla cookies ingredients contain Soy Lecithin: Contains: Wheat and Soy
AEQUALIS HUMERAL NAIL DRILL BIT, REF 7020140 Product Usage: The Aequalis Humeral Nail system is intended to provide temporary stabilization of various types of proximal and/or diaphyseal fractures of the humerus. Types of fractures include, but are not limited to, non-unions, malunions, malalignments, pathological fractures, and impending pathological fractures. Examples of specific indications according to AO classification include Type A-Fractures, dislocated, Type B Fractures, dislocated, Type C-Fractures, with intact humeral head, or Humeral Fractures according to Neer-Classification (2, 3 and 4 part fractures).
Sterile Aquasonic 100 Ultrasound Transmission Gel, 20 grams, Model Number 01-01-4, 400 packets/case
Wet-Field Hemostatic Eraser Bipolar 25G, fine tip, straight, 5/SP; Part Number 221267; UDI: 30886158010549
Apheresis Red Blood Cells, Leukocytes Reduced
Budget $aver Sugar Free Twin Pops Net Contents 28.2 FL OZ
Budget $aver Monster Cherry-Pineapple Pops Net Contents 36 FL OZ
Munk Pack PROTEIN COOKIE DOUBLE DARK CHOCOLATE NET WT 2.96oz (84g); UPC: 853787005368
Munk Pack PROTEIN COOKIE PEANUT BUTTER CHOCLATE CHIP NET WT 2.96oz (84g); UPC: 853787005351
(Item 829155) Product Usage: INTENDED FOR INJECTION OF U100 INSULIN ONLY
(Item 829555) Product Usage: INTENDED FOR INJECTION OF U100 INSULIN ONLY
Eden's Ethnos Bulk Kratom 25 powder kilogram bag Also called K. Bali Supreme, K Maeng Da Supreme, K Green Vein, Green Maeng Da, K Red Maeng Da, K Red Bali, K Green Bali Distributed by Eden Ethnos LLC, Carlsbad, CA 92010
Lean Pro 8 Chocolate 2,268g (5lb) Tub and Lean Pro 8 Chocolate 1,000g (2.2lb) Tub
Lean Pro 8 Cookies & Cream 1,000g (2.2lb) Tub
Sugarfina Platinum Bling Ring; Product SKU No. R-1790 UPC: 840278116139 Net W. 21g ().7 oz.) Sculpted from dark chocolate, these interlocking rings have a thin sugar shell brushed with edible silver: Ingredients: Dark Chocolate (cocoa, sugar, cocoa butter, soy lecithin (an emulsifier_ sugar, Dextrose, gum Arabic, color added, gelatin. Made in Greece Distributed by Sugarfina Inc. Santa Monica Blvd., Beverly Hills, CA
Pea Shoots Microgreens, Greenbelt Microgreens brand, net wt. 75 gram. Product is packaged in a clear plastic clam shell container. UPC 8 90082 00023 0
Fresh Microgreen Mix, Greenbelt Microgreens brand, net wt. 75 gram. Product is packaged in a clear plastic clam shell container. UPC 8 90082 00041 4
Sweet & Crunchy Microgreen Mix, Greenbelt Microgreens brand, net wt. 75 gram. Product is packaged in a clear plastic clam shell container. UPC 8 90082 00006 3
Spicy Microgreen Mix, Greenbelt Microgreens brand, net wt. 75 gram. Product is packaged in a clear plastic clam shell container. UPC 8 90082 00000 1
Broccoli Microgreens, Greenbelt Microgreens brand, net wt. 75 gram. Product is packaged in a clear plastic clam shell container. UPC 8 90082 00016 2
Sunflower Microgreens, Greenbelt Microgreens brand, net wt. 75 gram. Product is packaged in a clear plastic clam shell container. UPC 8 90082 00030 8
Arugula Microgreens, Greenbelt Microgreens brand, net wt. 75 gram. Product is packaged in a clear plastic clam shell container. UPC 8 90082 00012 4
OraVerse (Phentolamine Mesylate) Injection, 0.4 mg/1.7mL, packaged in a box of 10 cartridges of 0.4mg/1.7mL each, Rx only, Distributed by Septodont, Inc., Louisville, CO 80027, Made in Canada by Novocol Pharmaceutical of Canada, Inc., NDC 0362-0101-10
Metoprolol Succinate Extended-Release Tablets, USP, 100 mg, 100 Tablets bottle, Rx only, Manufactured by: Dr. Reddy's Laboratories Limited Bachupally-500 090 India\ NDC 55111-468-01
Lactosorb RapidFlap, bone plate, Model No. 915-0020 The RapidFlap LS Cranial Fixation System is indicated for use in pediatric craniotomy flap fixation.
Ampicillin and Sulbactam for Injection, USP, 3 gram*s/vial, packaged in 10-count vials per carton, Rx only, Distributed by: AuroMedics Pharma LLC, 279 Princeton-Hightstown Rd., E. Windsor, NJ 08520, NDC 55150-117-20.
STONEWALL KITCHEN Basil Pesto Aioli Net Weight Net 10.25 oz. UPC: 7 11381 03060 8. Product is incorrectly labeled as Basil Pesto, Net Weight 8 oz.
Asian Best, Tamarind Candy Net Weight: 4 oz. Units Per Carton: 72 units
Asian Best, Tamarind Candy Hot Flavor Net Weight: 4 oz. Units Per Carton: 72 units
Macroaggregated albumin (MAA) kit (for the preparation of Tc99m MAA), Aggregated and non-Aggregated Human Serum Albumin 2.5-5 mg Sodium Acetate Sol 200 mL/0.125 mL lyophilized powder in 10 mL glass vial, Rx only, AnazaoHealth, Tampa, FL
Acadica Kratom: Green Hulu 2 Kratom, 250g bags
Minivelle (estradiol transdermal system) 0.0375 mg/day, packaged in 8-systems per box, Rx only, Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 Dist. by: Noven Therapeutics, LLC Miami, Florida 33186, NDC 68968-6637-8
Minivelle (estradiol transdermal system) 0.1 mg/day, packaged in 8-systems per box, Rx only, Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 Dist. by: Noven Therapeutics, LLC Miami, Florida 33186, NDC 68968-6610-8
Soozie s Doozies Sugar Cinnamon Snickerdoodle Cookie Dough, 16 ounce, plastic pouch, 6 pouches per case

Product Quantity
1774 master cases (total for all products)
70 Seeds at 0.28mCi and 100 seeds at 0.36mCi

Reason for Recall
The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result in a difficult to/unable to disconnect condition of the mask from the elbow of the resuscitator.
Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or sulfapyridine causing falsely elevated or falsely depressed results.
There is a potential for leaking vials for certain lot numbers where, if proper attire is not used as instructed, a transient minor allergic skin reaction may result when handling leaking succinylacetone reagent vials.
Certain lots of disposable laparoscopic instrument tips may potentially have a compromised sterile barrier.
Calibration failure - confirmed a positive bias with LIPL lot FB8109 when compared to other Dimension LIPL lots. Lot FB8109 is not meeting Siemens internal specifications for lot-to-lot limits.
Falsely elevated results may be obtained when using the ARCHITECT DHEA-S assay with samples from infants up to 60 days old.
Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur FOL, ADVIA Centaur aHBcM and the following IMMULITE assays, 3gAllergy Specific IgE, anti-HBc, BR-MA (CA15-3), CEA, Folic Acid, Gastrin, OM-MA (CA125), Thyroglobulin, and Vitamin B12, and these assays are susceptible to interference from biotin.
The concentrations for biotin listed in the non-interfering substances section of the instructions for use for the Dimension TSHL, Dimension LOCI FT4L, Dimension Vista TSH, ADVIA Centaur Cyclosporine, and ADVIA Centaur DHEAS, incorrectly state the level at which biotin does not interfere.
The concentrations for biotin listed in the non-interfering substances section of the instructions for use for the Dimension TSHL, Dimension LOCI FT4L, Dimension Vista TSH, ADVIA Centaur Cyclosporine, and ADVIA Centaur DHEAS, incorrectly state the level at which biotin does not interfere
Reports of product loosening or coming unscrewed from the handle.
The ECG signal may flatline due to electromagnetic interference during the use of electrosurgical equipment.
Beckman Coulter has determined that there is a potential for incorrect settings to be installed on North American iChemVELOCITY Urine Chemistry Analyzers. 1. The installation of International settings can result in the generation of erroneous, false low results for some of the analytes at some concentrations. 2. The installation of colors different from those stated in the Instructions for Use (Colorless, Straw, Yellow, Amber, Red, Blue) for output settings will result in incorrect reporting of colors. For example, if Green is the color choice for the output setting instead of Blue, Green will be reported.
Incorrect product and/or label. Sizing is labeled incorrectly.
Potential for Capio sutures to break and /or detach.
There is a possibility of low volume and/or leaking standard bottles.
Module may freeze without generating user warning. There is a potential risk in delay of sample processing, leading to delayed delivery of test results to patients.
The firm received complaints of drill bits breaking during use with the Prestige LP(TM) Cervical Disc System. Subsequent investigation demonstrated the interaction of the drill guide and the drill bit may lead to drill bit breakage.
Specific lots of the device were overexposed during EtO sterilization. This may lead to revision due to infection from loss of sterile barrier during over-exposure cycle.
Incorrect calibrator level listed in qualitative calibration steps
A change regarding the shelf life of a raw material was implemented without an appropriate submission of data demonstrating the continued efficacy of the product.
The firm has received 106 complaints of the device breaking in the patient's mouth. Device breakage may cause injury to the patient.
Software upgrade to correct format of study dates and issues with Legacy Presentation States (annotations) in order to prevent potential patient misdiagnosis.
The sterility of the device cannot be assured. There is a potential for an increased risk of infection.
Potential friction holes may affect the sterility of the product.
Incorrect gel part number listed in a master manufacturing record
Randox has now released further steps to avoid contamination of the Lipase Assay on Rx instruments.
The automatic ventilation may fail if the position detection of the motor is disturbed. If the ventilator cover is damaged, manual ventilation may also fail.
Multiple products marketed as dietary supplements are unapproved new drugs based on disease claims or routes of administration.
Cap-adapter assembly of the device may potentially not be adequately tightened, possibly leading to fluid leakage from or air aspiration into the connecting tube.
Slot screw had an overall length of 15mm, but per the specification, the screw should have an overall length of approximately 17mm.
Incorrect package insert indicating use of the kits with plasma, serum, and other biological fluids. The kits should only be used with plasma.
All Kratom products manufactured, processed, packed, and/or held by Triangle Pharmanaaturals LLC have the potential to be contaminated with Salmonella
There is a possibility for the clamps of the gas bottle holder to crack or break when exposed to strong vibrations.
When continuous cardiac output monitoring with a pulmonary artery catheter is placed in the Pause mode, the catheter thermal coil may continue while in pause mode.
Service technician improperly documented final release testing on product, indicating that the full battery of release tests were performed when, in fact, several tests were omitted. he omitted tests include air-in-line detection at 400ml/hr and 800ml/hr and verification of upstream occlusion detection at 800ml/hr. Improper detection of air-in-line or upstream occlusion may result in serious adverse health consequences.
The DC power to the IFOSS collision detector control panel at your facility is being adversely affected by the magnetic field. Our investigation shows the magnetic field is causing the IFOSS control panel to malfunction.
There may be burrs on the extraction hole threads.
The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions.
There is a potential for microspores to form on the hollow handle of the Sciatic Nerve Retractor. The pores may increase in size, allowing fluid to enter the hollow handle.
Samples collected by public health officials found the presence of Salmonella.
The firm was marketing the Ondamed System in the US without marketing clearance. As a corrective action, the firm revised its device design to comply with regulations. The firm has notified customers that an upgrade for the device is now available, which includes the addition of direct readout and audio signals for heart rate, and visual patient readout of blood oxygen content SpO2.
The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Seal separation from the housing may allow air to enter the housing and collapse the balloon. This may increase resistance to flow in the venous line and cause a drop in ECMO circuit blood flow.
Distal tips of the probes may detach from the probe shaft during use.
not functioning properly. The corrected values modified in the report are neither saved, nor printed, nor sent to the information system. The system will still use original values.
Superior Foods Company is voluntarily recalling a specific lot of Smoked Salmon Spreads that were produced on March 26, 2018, due to potential contamination with Listeria monocytogenes.
While packing from a bulk bin of whole wheat chocolate animal cookies, 2 whole wheat vanilla animal cookies were discovered. The vanilla cookies contain soy lecithin that is not declared on the chocolate cookie label.
Drill bit tips without new BargerGard tip protector may puncture through sterile packaging.
There is a potential for the gel packets to have leaks in the packet seal.
Products were packaged with incorrect labeling,
Apheresis product, which was irradiated labeled with an incorrect expiration date, was distributed.
The Colorado Department of Public Health & Environment notified the firm that they had recovered Listeria monocytogenes from multiple environmental sampling sites collected during an inspection at their Denver plant.
The retail shelf cartons may be labeled with an incorrect lot number.
FDA and state samples found Salmonella in Kratom products that traced back to Eden Ethnos LLC.
Internal audit discovered that their Platinum Bling Ring product contains fish gelatin that is not declared on the ingredient or allergen information
Pea Shoots Microgreens product is recalled due to a potential to be contaminated with Listeria monocytogenes.
Fresh Microgreen Mix product is recalled due to a potential to be contaminated with Listeria monocytogenes.
Sweet & Crunchy Microgreen Mix product is recalled due to a potential to be contaminated with Listeria monocytogenes.
Spicy Microgreen Mix product is recalled due to a potential to be contaminated with Listeria monocytogenes.
Broccoli Microgreens product is recalled due to a potential to be contaminated with Listeria monocytogenes.
Sunflower Microgreens product is recalled due to a potential to be contaminated with Listeria monocytogenes.
Arugula Microgreens product is recalled due to a potential to be contaminated with Listeria monocytogenes.
Failed Impurities/Degradation: This recall has been initiated due to an out of specification (OOS) result that was obtained for related substance (Phentolamide), a known degradation product impurity at the 15 month stability test point.
Presence of Foreign Tablets/Capsules: One foreign tablet identified as Clopidogrel 75 mg was found in a 100 count bottle of Metoprolol Succiante Extended-Release Tablets.
The recalling firm has confirmed that the Outer Plate component exhibits an excessive chamfer on the threading after deburring operations. This excessive chamfer results in non-conforming product where the threads of the outer plate component have limited to no engagement with the post component.
Presence of Particulate Matter: confirmed customer report of the presence of visible particulate matter believed to be red rubber particles from the manufacturing process of the active ingredients.
Eastland Food Corporation out an abundance of caution has decided to initiate a product recall of all Asian Best, Tamarind Candy ( UPC: 083737158008 ) and Tamarind Candy Hot Flavor ( UPC: 083737158022 ) due to elevated levels of lead (0.15 ppm) when compared against FDA s action level of 0.1 ppm.
100% Whole Wheat Bread Mix is recalled due to undeclared wheat in the label on the back side of the package.
Recalling Red Suma, Green Suma, Red Hulu 2, Green Hulu 2 Kratom products due to potential salmonella.
Blood products collected from a donor whose arm cleansing procedures were performed using an expired cleanser, were distributed.
Defective Delivery System: Product is out of specification for shear
National Foodworks Services is voluntarily recalling Soozie s Doozies Sugar Cinnamon Snickerdoodle Cookie Dough due to contamination with Staphylococcus aureus.

Code Info
SIRO, sirolimus test system, DF306, SMN# 10464331 Lot codes: BB7336 FA8037 FA8081 BB8167 FB8177 FB8219
OM-MA (CA125), OM-MA (CA125) (IMMULITE/IMMULITE 1000, LKOP1), (IMMULITE 2000/IMMULITE 2000 XPi, LKOP2) Lot codes: CA125 (OM-MA) 0211 0212 0213
OM-MA (CA125), OM-MA (CA125) (IMMULITE/IMMULITE 1000, LKOP1), (IMMULITE 2000/IMMULITE 2000 XPi, LKOP2) Lot codes: CA125 (OM-MA) 287 289 290
CEA, CEA (IMMULITE/IMMULITE 1000, LKCE1), (IMMULITE 2000/IMMULITE 2000 XPi, LKCE2, LKCE6) Lot codes: 0355 0356 0357
TSHL, radioimmunoassay, thyroid-stimulating hormone, RF612, SMN# 10464524 Lot codes: EB7276 EC7298 EA7318 EB7346 EC7346 EA8012 EA8033 EA8051 EC8080 EB8107 EB8121 EA8143 EB8143 EA8177 EB8177 EB8199 EA8223 EA8241 EA8261
CEA, CEA (IMMULITE/IMMULITE 1000, LKCE1), (IMMULITE 2000/IMMULITE 2000 XPi, LKCE2, LKCE6) Lot codes: 0355 0356 0357 CEA Lot # 200 tests 311 312 313
MMB, colorimetric method, cpk or isozymes, K6420, SMN# 10445097 Lot codes: 16284BD 16312BB 17011BD 17058BD 17093BC 17136BE 17186BE 17235BC 17268BA
BR-MA/CA15-3, BR-MA/CA15-3 (IMMULITE/IMMULITE 1000, LKBR1), (IMMULITE 2000/IMMULITE 2000 XPi, LKBR2) CA15-3(BR-MA) Lot # 265 266 267
TSH, radioimmunoassay, thyroid stimulating hormone, RF612, SMN# 10464524 Lot codes: 16277BD 16322BB 17005BB 17023AC 17069AA 17093BB 17122AA 17150AA 17193BA 17215AC 17268AA
Vitamin B12, Vitamin B12 (IMMULITE/IMMULITE 1000, LKVB1) Lot codes: 0338 0339 0340 0341
BR-MA/CA15-3, BR-MA/CA15-3 (IMMULITE/IMMULITE 1000, LKBR1), (IMMULITE 2000/IMMULITE 2000 XPi, LKBR2) Lot codes: 0312 0313
Gastrin, Gastrin (IMMULITE/IMMULITE 1000, LKGA1), (IMMULITE 2000/IMMULITE 2000 XPi, LKGA2) Lot codes: Gastrin Lot # 0345 0346 0347
Folic Acid, Folic Acid (IMMULITE 2000/IMMULITE 2000 XPi L2KFO2, L2KFO6) Lot codes: Folic Acid Lot # 502 503 504 505 506 508 514
TG, TG (IMMULITE/IMMULITE 1000, LKTY1(D)), (IMMULITE 2000/IMMULITE 2000 XPi, LKTY2(D)) Lot codes: 0289 0290 0291 D0289 D0290 D0291
Gastrin, Gastrin (IMMULITE/IMMULITE 1000, LKGA1), (IMMULITE 2000/IMMULITE 2000 XPi, LKGA2) Lot codes: 251 252 253 254 255
Anti HBc, Anti HBc (IMMULITE 2000/IMMULITE 2000 XPi L2KHC2 (D)) Lot codes: Anti HBcM # 579 580 581 D579 D580 D581
3g Allergy specific IgE Universal kit, 3g Allergy specific IgE Universal kit (IMMULITE 2000/IMMULITE 2000 XPi L2KUN6 (D)) Lot codes: 3g Allergy Specific IgE Lot # 461 462 463 464 465 466 467 468 469 470 471 472 473 475 476 3g Allergy Specific IgE Lot # D463 D464 D465 D466 D467 D469 D471 D472 D476 D483
Software versions VB20A, VB20B, or VB20C that have a common physio module (CPM) (known by customers as the ECG (physio) hardware) installed at revision 4
All Fielded Serial Numbers with North American Configuration settings
Serial Numbers: Accelerator a3600 - ACP.150 ACP.185 ACP.186 ACP.192 ACP.202 ACP.214 FlexLab - FLX.0165 FLX.0127 FLX.0128 FLX.0133 FLX.0157 FLX.0160 FLX.0181 Aptio Automation - AP2.0054 AP2.0056 AP2.0060 AP2.0078 AP2.0095 Part Numbers of impacted sample tube carriers: 721501001 for 43 mm carriers, and 0A00006957 for 40 mm carriers
Lot LZ713, Syringe Blaster Lot LP632B, Exp 6/30/2018 Lot MZ542, Syringe Blaster Lot LP632B, Exp 6/30/2018 Lot MG933, Syringe Blaster Lot LP632B, Exp 6/30/2018 Lot MZ543, Syringe Blaster Lot MG253C, Exp 9/30/2018 Lot NJ581, Syringe Blaster Lot MG253C, Exp 9/30/2018 Lot NJ582, Syringe Blaster Lot NA438B, Exp 3/31/2019 Lot NP345, Syringe Blaster Lot NE101B, Exp 3/31/2019
Lot MZ538, Syringe Blister Lot MG253B, Exp 9/4/2018 Lot NJ580, Syringe Blister Lot MG253B, Exp 9/30/2018 Lot NK215, Syringe Blister Lot NE101A, Exp 3/31/2019 Lot NP343, Syringe Blister Lot NE101A, Exp 3/31/2019
Lot NY938, Syringe Blister Lot MN843, Exp 11/30/2018 Lot NP738, Syringe Blister Lot NE101A, Exp 3/31/2019 Lot PG629, Syringe Blister Lot NK216, Exp 5/31/2019 Lot PY817, Syringe Blister Lot PT888C, Exp 1/31/2020
Lot NZ535, Syringe Blaster Lot LP632A, Exp 6/30/2018 Lot PG631, Syringe Blaster Lot MX842B, Exp 2/28/2019 Lot NP739, Syringe Blaster Lot NE101B, Exp 3/31/2019 Lot PY818, Syringe Blaster Lot PT888A, Exp 1/31/2020
Lot NP737, Syringe Blister Lot NA438A, Exp 3/31/2019; Lot PG628, Syringe Blister Lot NF819A, Exp 3/31/2019; Lot PY816, Syringe Blister Lot PT888C, Exp 1/31/2020; Lot NY939, Syringe Blister Lot, NA438A, Exp 3/31/2019
Lot LT830, Syringe Blister Lot LK692B, Exp 5/31/2018 Lot LZ706, Syringe Blister Lot LK692B, Exp 5/31/2018 Lot MG929, Syringe Blister Lot LK692B, Exp 5/31/2018 Lot MT037, Syringe Blister Lot MG253A, Exp 9/30/2018 Lot MZ441, Syringe Blister Lot MG253A, Exp 9/30/2018 Lot NJ289, Syringe Blister Lot MG253A, Exp 9/30/2018 Lot NJ579, Syringe Blister Lot NA438A, Exp 3/31/2019 Lot NP340, Syringe Blister Lot NA438A, Exp 3/31/2019
All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018
Lot Number HC1179, GTIN Number 10603295042181; Lot Number HC1183, GTIN Number 10603295042181
Lot Number HD6516, GTIN Number 10603295042280
Smoked Salmon Spread 5 lb. bulk units Code Number: 68487 Sell by Date: 4/25/18 Lot Number 0728-2 UPC #043823684873 Simply Superior Smoked Salmon Spread 6X5 oz units Code Number: 92379 Sell by Date: 4/25/18 Lot Number 0728-2 UPC #043823923798 Morey s Smoked Salmon Spread 6x6 oz units Code Number: 92503 Sell by Date: 4/25/2018 Lot Number 0728-2 UPC #043823925037
Best by 16 JUL 2019. 249490 05:24 14 01 2018 (05:24 stands for production time and 14 01 2018 stands for production date of January 14, 2018)
Everything manufactured between 1/1/18 to 4/12/18.