Recalling Firm
Stryker Instruments Div. of Stryker Corporation
Mesa Laboratories Bozeman Manufacturing Facility
Mindray DS USA, Inc. dba Mindray North America
Konica Minolta Medical Imaging USA, Inc.
Schwartz Brothers Restaurants dba Schwartz Brothers Bakery
Taylor Farms California Foodservice, Inc.

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

Distribution Pattern
USA: MI FL CA TX India, Russia, Puerto Rico, N. Mariana Island/Palau.
Worldwide distribution US nationwide, Canada, Chile, Costa Rica, Denmark, France, Hungary, Italy, Japan, Lebanon, Portugal, Serbia, Spain, and Taiwan.
Worldwide distribution. US nationwide including Puerto Rico, Korea, Czech Republic, China, Japan, Great Britain, Austria, Malaysia, Hong Kong, Russia, Taiwan, Singapore, India, and Brazil
International Distribution to: Germany only.
Worldwide Distribution: US (Nationwide) and countries of: New Zealand, Saudi Arabia, Switzerland, United Arab Emirates Uruguay & Republic of Macedonia (The former Yugoslav Republic of Macedonia).
US, Canada, China, Sweden, Germany, Japan, Qatar, France, Audtralia
Worldwide Distribution - USA (nationwide) Distribution to the states of : AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV, WY, and the District of Columbia. and to the countries of : Argentina, Chile, Mexico, Panama, Canada, Australia, New Zealand, Austria, Bahrain, Belgium, Bulgaria, Croatia, Czech Republic, Egypt, Estonia, France, Germany, Greece, Hungary, Ireland, Italy, Jordan, Kuwait, Latvia, Lebanon, Lithuania, Morocco, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, United Kingdom, Israel, Netherlands, Tunisia, Brunei, Indonesia, Malaysia, Myanmar, Philippines, Singapore, Thailand, and Vietnam
United States, Republic of Korea, Israel, Poland, France, China, Canada, Japan, Singapore, Hong Kong, Jordan
Worldwide distribution. Austria, Denmark, Germany, Singapore, Netherlands, Hong Kong, and Switzerland. US product is not affected.
Worldwide Distribution: US (nationwide) including states of: AL, CA, FL, GA, IL, IN, MN, OR, TN, TX, VA, and WA; and countries of: Argentina, Austria, Belgium, Brazil, Canada, France, Germany, India, Iraq, Israel, Italy, Japan, Lebanon, Malaysia, Mexico, Namibia, Pakistan, Peru, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Spain, South Africa, Switzerland, Taiwan, and United Arab Emirates.
There was no U.S. distribution. Distribution was made to Panama and United Kingdom.
USA (nationwide) Distribution to the states of : AL, AR, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI., and Internationally to Japan and Netherlands.
Distributed in the following U.S. states: AZ, CA, CT, IN, MD, MI, MN, NJ, NY, OR, WA, and Puerto Rico. Distributed in China and India.
Worldwide and US of Indiana and country of the Republic of Korea.
Worldwide Distribution: US (nationwide) and countries of: Austria, Belgium, Canada, Denmark, France, Germany, Italy, Netherlands, Slovakia, Spain and Switzerland.
distributed in CA, CO, CT, IA, KS, FL, MD, MI, MN, MO, ND, NE, NJ, NV, NY, OR, PA, TX, UT, VA, and WA
Distributed in all 50 U.S. States and the District of Columbia. Distributed in Australia, Argentina, Japan, Canada, Chile, Korea, Spain, France, Italy, Netherlands, and United Kingdom.
Worldwide Distribution - U.S. Nationwide in the states: AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WY, including Puerto Rico and distributed to 30 foreign consignees.
The devices have been distributed within the United States and the following countries: United Arab Emirates, Argentina, Austria, Australia, Barbados, Belgium, Bulgaria, Bermuda, Brazil, Canada, Switzerland, Colombia, Costa Rica, Cyprus, Czech Republic, Germany, Denmark, Spain, Finland, Faroe Islands, France, United Kingdom, Guatemala, Hong Kong, Hungary, Indonesia, Ireland, Iceland, Italy, Jamaica, Jordan, Japan, Kenya, South Korea, Kuwait, Lebanon, Latvia, Morocco, Macedonia, Mexico, Netherlands, New Zealand, Oman, Panama, Poland, Portugal, Serbia, Saudi Arabia, Sweden, San Marino, El Salvador, Turkey, Trinidad & Tobago, Ukraine, Uruguay, Venezuela, Virgin Islands, Kosovo, China, and South Africa.
Distributed in the following U.S. states: AL, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, WA, WI and the District of Columbia. Distributed in Canada and Brazil.
Worldwide Distribution - U.S. Nationwide in the states of: CA, CO, FL, IN, MA, NE, NJ, OH, TN, TX, and WI. and countries of Belarus, Belgium, Brazil, Canada, Chile, China, Egypt, Italy, Japan, Poland, Saudi Arabia, Spain, and United Kingdom.
Nationwide (U.S.): SC, FL, WA, KS, GA, NC, TX, TN, OH, MT, & AL
Distributed in the following U.S. states: CO, FL, IL, NC, PA, SC, and TX.
Worldwide Distribution - USA (nationwide) Distribution including Puerto Rico and to the states of : AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, and the District of Columbia., and to the countries of : Australia, Austria, Belgium, Canada, Croatia, Denmark, Finland, France, Germany, India, Ireland, Italy, Korea, Luxembourg, Malaysia, Netherlands, Portugal, Singapore, Slovakia. Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, and United Kingdom.
Product was distributed online via eBay.
Product was distributed throughout the United States, Hong Kong and New Zealand.
Worldwide Distribution: US (nationwide) AK, AL, AR, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and Puerto Rico; and countries of: Australia, Brazil, Canada, Chile, Colombia, El Salvador, Netherlands, Japan, Costa Rica, Spain, and Thailand.
US, Canada, China, Australia, Sweden, Germany
Wegmans Stores in NY, NJ, PA, VA, MD and MA.
US Distribution to states of: AZ, IL NC, NH and PA.
Medical device software which needs to be installed.
Product was distributed in the following states: AL, CA, FL, GA, IN, LA, MO, MS, OH, OK, PA, SC, TN, TX, WI and WV.
The product has been distributed to the following States: AZ, CA, CT, GA, IL, KY, ME, NC, NJ, NY, Ok, PA, VA
Domestic: IL, TX, VA, WI, OK, MS Foreign: Canada
OK, OH, MI, MN, IA, CA, KS, WI, PA, OR, WA FL
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.
One distributor in CA and to retail stores in CA, HI, NV.
Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Australia, France, Saudi Arabia, Germany, and France.
Distributed in AZ. No VA/Govt/Foreign consignees.

Product Description
EasyCAL HbA1c Calibrator; REF 10658 Kit is packaged in a paper box containing 4 vials of 0.25ml of calibrant, one for each calibration level, and an insert sheet.
Tapered Screw-Vent MTX, Dental Implant, sterile. Model TSVTB10.
Tapered Screw-Vent MTX, Dental Implant, sterile. Model TSV4B10.
Lithium Heparin Plasma Blood Collection Tubes for Invitro Diagnostic Use, Catalog Numbers: 365043, 365044, 365045 & 365047 Used to collect, separate, process, transport and store venous blood samples for use in chemistry determinations, therapeutic drug monitoring and zinc testing in plasma for in vitro diagnostic use.
c6000, Chemistry (Photometric, Discrete), for clinical use. - cobas e 601 module: Immunoassay Analyzer, Catalog Numbers: 04745922001, 05036348001, 05860652001, 04745922692, 05036348001 & 05036348692
cobas e 411 Immunoassay Analyzer (Discrete Photometric Analyzer for Clinical use), Catalog Numbers: 04775201001 (rack system), 04775279001 (disk system), 04775201973 (rack system) & 04775279973 (disk system).
Modular E 170 Analyzer: Immunoassay Chemistry Analyzer, Chemistry (Photometric, Discrete) for clinical use, Catalog Numbers: 03739040692, 03023109001, 05023599001, 05023572001, 03739040001 & 03023109973.
ACUVUE ADVANCE Brand Contact Lenses with HYDRACLEAR
ACUVUE OASYS Brand Contact Lenses with HYDRACLEAR PLUS
1-DAY ACUVUE Moist for ASTIGMATISM Brand Contact Lenses
Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 54mm, REF 804-07-540 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as an anatomic shoulder joint replacement for patients suffering from pain and dysfunction.
Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 46mm, REF 804-07-460 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as an anatomic shoulder joint replacement for patients suffering from pain and dysfunction.
Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 50mm, REF 804-07-500 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as an anatomic shoulder joint replacement for patients suffering from pain and dysfunction.
Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 38mm, REF 804-07-380 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as an anatomic shoulder joint replacement for patients suffering from pain and dysfunction.
Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 42mm, REF 804-07-420 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as an anatomic shoulder joint replacement for patients suffering from pain and dysfunction.
Sofia 2 Analyzer Catalog Number 20299 Sofia 2 is a bench top analyzer intended to be used with Cassette-based immunofluorescent in vitro diagnostic assays . Sofia 2 is intended for professional and laboratory use.
Teleflex MEDICAL WECK Visistat 35. Used for the external skin closure of lacerations.
Flucanazole Injection, USP 200 mg in in 100 mL (2 mg/mL), 10 Single Dose Flexible Containers, Rx Only, Manufactured for: Claris Lifesciences, Inc. North Brunswick, NJ 08902 By; Claris Injectables Ltd. Gujarat, India --- NDC 36000-006-10
Evamist (estradiol transdermal spray), 1.53mg estradiol/spray, 0.27 fl oz (8.1 mL) per bottle, Rx Only, Manufactured for Perrigo, Minneapolis, MN 55427. NDC: 0574-2067-27
The Stryker Thoracic Pedicle Feeler 6002-350-000 is a smart instrument for remote control of the navigation software and creation of a pathway into the pedicle. The instrument has three types of buttons to remotely control the software: the UP, DOWN and SELECT buttons. The Pedicle Feeler is laser marked in 10 mm intervals to help indicate the depth in which the feeler tip has been inserted into the pedicle. Next to the navigational information, these depth indicators on the feeler tip are also helpful in determining the appropriate pedicle screw length.
Connector, REF/Catalog Number 2602M Indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single pediatric use, only. The PadPro 2602 electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (non-invasive) cardiac pacemaker and the pediatric patients skin. The electrode is intended for use on pediatric infants whose weight is less than 10 kg. (22 lbs.).
MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Philips Plug Style Connector, REF/Catalog Number 2602H Indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single pediatric use, only. The PadPro 2602 electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (non-invasive) cardiac pacemaker and the pediatric patients skin. The electrode is intended for use on pediatric infants whose weight is less than 10 kg. (22 lbs.).
MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Universal/Anderson Connector, REF/Catalog Number 2602 Indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single pediatric use, only. The PadPro 2602 electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (non-invasive) cardiac pacemaker and the pediatric patients skin. The electrode is intended for use on pediatric infants whose weight is less than 10 kg. (22 lbs.).
AltiVate Reverse INSTRUMENTATION, HUMERAL SOCKET SHELL TRIAL, STANDARD, REF 804-06-152, Qty: 01, Encore Medical, LP Orthopedic surgical instrument. Product Usage: The humeral socket shell trial is used to replicate/trial the shell geometry of the AltiVate Reverse Standard Shell Humeral Stem implants. It assembles to the humeral broaches by a screw in order to replicate/trial the entire humeral stem implant geometry prior to implantation.
IMRIS ORT200 Removable Operating Room Table, 50-60 Hz Version is intended for use during diagnostic examinations or surgical procedures to support and position a patient.
IMRIS ORT300 Removable Operating Room Table, 50-60 Hz Version is intended for use during diagnostic examinations or surgical procedures to support and position a patient.
Rechargeable Li-ion battery used with Puritan Bennett TM 980 Series Ventilator System including Pediatric-Adult Ventilator, Neonatal Ventilator, Universal Ventilator; Battery Product Number: 10086042; UDI: 20884521700861 The rechargeable lithium-ion batteries are intended to provide a backup power source to the ventilator in case AC power is lost.
ProSpore Biological Indicator Part Numbers: PS-6-50, PS-5-50, PS-4-10, PS-4-50, 3471
SporAmpule Biological Indicator Catalog Number SPS5-100
Nucleic Acid test intended for screening for MRSA/SA. Each kit has 20 tubes. in vitro diagnostic.
The FEMTO LDV(TM)Z8 Femtosecond Surgical Laser The FEMTO LDV(TM)Z8 Femtosecond Surgical Laser is an ophthalmic surgical laser intended for use in the creation of corneal incisions indicated for use in patients undergoing LASIK surgery, tunnel creation for implantation of rings, pocket creation for implantation of corneal implants, lamellar keratoplasty, penetrating keratoplasty or other treatment requiring lamellar resection of the cornea at a varying depth with respect to the corneal surface. In addition, the FEMTO LDV(TM)Z8 Surgical Laser is intended for use in the creation of capsulotomy, phacofragmentation and the creation of single plane, multi-plane, arc cuts/incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure indicated for use in patients undergoing cataract surgery for removal of the crystalline lens.
QUANTA-Lyser 240 EIA, Part #GS0241. The instrument is a fully automated, high-throughput, bench top system designed for clinical use to automate slide and reagent barcode reading, sample dilution and distribution, reagent pipetting and dispensing, slide and plate washing, dispensing slide mounting medium in the preparation for microscope analysis, and photometric measurement of microwell plates.
QUANTA-Lyser 240 IFA, Part #GS0242. The instrument is a fully automated, high-throughput, bench top system designed for clinical use to automate slide and reagent barcode reading, sample dilution and distribution, reagent pipetting and dispensing, slide and plate washing, dispensing slide mounting medium in the preparation for microscope analysis, and photometric measurement of microwell plates.
Persona Partial Knee spacer block instruments; (1) 8mm block, Model Number: 42-5399-035-08; (2) 9mm block, Model Number:42-5399-035-09; (3) 10mm block, Model Number: 42-5399-035-10; (4) 12mm block, Model Number: 42-5399-035-12; (5) 14mm block, Model Number: 42-5399-035-14 A spacer block is used to ensure the tibial resection Is sufficient and to verify limb alignment. After verification the distal femoral resecUon Is complete using the distal femoral cut slot in the spacer block. The spacer block determines how much distal femoral bone is resected.
indicated for patients with severe knee pain and disability due to: - Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
Persona Partial Knee Spacer Blocks To assist in partial knee arthroplasty surgery
Comprehensive Segmental Revision System (SRS)
Coonrad/Morrey Elbow Implant System humeral assembly 4IN XSML, Item Number: 32-8105-027-04 (UDI: (01)0088902427 4006(17)220731(10)63694912)
Zimmer M/L Taper Hip Prosthesis, 7711 Series, Femoral Stem 12/14 Neck Taper Plasma Sprayed Press-Fit Cementless Size 4 Standard Reduced Neck Length; Part Number: 00-7711-004-10
Zimmer M/L Taper Hip Prosthesis, 7711 Series, Femoral Stem 12/14 Neck Taper Plasma Sprayed Press-Fit Cementless Size 7.5 Extended Offset Reduced Neck Length; Part Number: 00-7711-007-40
ACE Trochanteric Nail System STER L H TROC NAIL 320X9X125 STER L H TROC NAIL 340X9X125 STER L H TROC NAIL 360X9X125 STER L H TROC NAIL 380X9X125 STER L H TROC NAIL 400X9X125 STER L H TROC NAIL 420X9X125 STER L H TROC NAIL 440X9X125 STER L H TROC NAIL 460X9X125 STER L H TROC NAIL 320X11X125 STER L H TROC NAIL 340X11X125 STER L H TROC NAIL 360X11X125 STER L H TROC NAIL 380X11X125 STER L H TROC NAIL 400X11X125 STER L H TROC NAIL 420X11X125 STER L H TROC NAIL 440X11X125 STER L H TROC NAIL 460X11X125 STER L H TROC NAIL 320X13X125 STER L H TROC NAIL 340X13X125 STER L H TROC NAIL 360X13X125 STER L H TROC NAIL 380X13X125 STER L H TROC NAIL 400X13X125 STER L H TROC NAIL 420X13X125 STER L H TROC NAIL 440X13X125 STER L H TROC NAIL 460X13X125 STER R H TROC NAIL 320X9X125 STER R H TROC NAIL 340X9X125 STER R H TROC NAIL 360X9X125 STER R H TROC NAIL 380X9X125 STER R H TROC NAIL 400X9X125 STER R H TROC NAIL 420X9X125 STER R H TROC NAIL 440X9X125 STER R H TROC NAIL 460X9X125 STER R H TROC NAIL 320X11X125 STER R H TROC NAIL 340X11X125 STER R H TROC NAIL 360X11X125 STER R H TROC NAIL 380X11X125 STER R H TROC NAIL 400X11X125 STER R H TROC NAIL 420X11X125 STER R H TROC NAIL 440X11X125 STER R H TROC NAIL 460X11X125 STER R H TROC NAIL 320X13X125 STER R H TROC NAIL 340X13X125 STER R H TROC NAIL 360X13X125 STER R H TROC NAIL 380X13X125 STER R H TROC NAIL 400X13X125 STER R H TROC NAIL 420X13X125 STER R H TROC NAIL 440X13X125 STER R H TROC NAIL 460X13X125 STER L H TROC NAIL 320X11X130 STER L H TROC NAIL 320X9X130 STER L H TROC NAIL 340X9X130 STER L H TROC NAIL 360X9X130 STER L H TROC NAIL 380X9X130 STER L H TROC NAIL 400X9X130 STER L H TROC NAIL 420X9X130 STER L H TROC NAIL 440X9X130 STER L H TROC NAIL 460X9X130 STER L H TROC NAIL 340X11X130 STER L H TROC NAIL 360X11X130 STER L H TROC NAIL 380X11X130 STER L H TROC NAIL 400X11X130 STER L H TROC NAIL 420X11X130 STER L H TROC NAIL 440X11X130 STER L H TROC NAIL 460X11X130 STER L H TROC NAIL 320X13X130 STER L H TROC NAIL 340X1
ACE Trochanteric Nail System ATN AR SCREW 60MM STERILE ATN AR SCREW 65MM STERILE The Trochanteric Nail System is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures and combinations of these fractures. The Trochanteric Long Nail System is additionally indicated to treat pertrochanteric fractures associated with shaft fractures, pathologic fractures in osteoporotic bone of the trochanteric and diaphyseal areas, long subtrochanteric fractures, ipsilateral femoral fractures, proximal or distal nonunions and malunions and revision procedures.
ACE Trochanteric Nail System ATN LAG SCREW 60MM STERILE ATN LAG SCREW 65MM STERILE ATN LAG SCREW 70MM STERILE ATN LAG SCREW 75MM STERILE ATN LAG SCREW 80MM STERILE ATN LAG SCREW 85MM STERILE ATN LAG SCREW 90MM STERILE ATN LAG SCREW 95MM STERILE ATN LAG SCREW 100MM STERILE ATN LAG SCREW 105MM STERILE ATN LAG SCREW 110MM STERILE ATN LAG SCREW 115MM STERILE ATN LAG SCREW 120MM STERILE ATN LAG SCREW 125MM STERILE ATN LAG SCREW 130MM STERILE The Trochanteric Nail System is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures and combinations of these fractures. The Trochanteric Long Nail System is additionally indicated to treat pertrochanteric fractures associated with shaft fractures, pathologic fractures in osteoporotic bone of the trochanteric and diaphyseal areas, long subtrochanteric fractures, ipsilateral femoral fractures, proximal or distal nonunions and malunions and revision procedures.
ACE Trochanteric Nail System STER TROC LAG SCR 70 MM The Trochanteric Nail System is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures and combinations of these fractures. The Trochanteric Long Nail System is additionally indicated to treat pertrochanteric fractures associated with shaft fractures, pathologic fractures in osteoporotic bone of the trochanteric and diaphyseal areas, long subtrochanteric fractures, ipsilateral femoral fractures, proximal or distal nonunions and malunions and revision procedures.
ACE Trochanteric Nail System STER TROC NAIL 125 DEG X 9MM STER TROC NAIL 130 DEG X 9MM STER TROC NAIL 135 DEG X 9MM The Trochanteric Nail System is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures and combinations of these fractures. The Trochanteric Long Nail System is additionally indicated to treat pertrochanteric fractures associated with shaft fractures, pathologic fractures in osteoporotic bone of the trochanteric and diaphyseal areas, long subtrochanteric fractures, ipsilateral femoral fractures, proximal or distal nonunions and malunions and revision procedures.
ACE Trochanteric Nail System STER TROC END CAP STER TROC END CAP 5MM STER TROC END CAP 10MM STER TROC END CAP 15MM STER TROC END CAP 20MM STER TROC END CAP 25MM The Trochanteric Nail System is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures and combinations of these fractures. The Trochanteric Long Nail System is additionally indicated to treat pertrochanteric fractures associated with shaft fractures, pathologic fractures in osteoporotic bone of the trochanteric and diaphyseal areas, long subtrochanteric fractures, ipsilateral femoral fractures, proximal or distal nonunions and malunions and revision procedures.
ACE Trochanteric Nail System ACE TROCH NAIL 125 DEG. X 11MM ACE TROCH NAIL 130 DEG. X 11MM ACE TROCH NAIL 135 DEG. X 11MM ACE TROCH NAIL 125 DEG. X 13MM ACE TROCH NAIL 130 DEG. X 13MM ACE TROCH NAIL 135 DEG. X 13MM The Trochanteric Nail System is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures and combinations of these fractures. The Trochanteric Long Nail System is additionally indicated to treat pertrochanteric fractures associated with shaft fractures, pathologic fractures in osteoporotic bone of the trochanteric and diaphyseal areas, long subtrochanteric fractures, ipsilateral femoral fractures, proximal or distal nonunions and malunions and revision procedures.
ACE Trochanteric Nail System STER TROC NAIL 180X11X140 STER TROC NAIL 125 DEG X 11MM STER TROC NAIL 130 DEG X 11MM STER TROC NAIL 135 DEG X 11MM The Trochanteric Nail System is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures and combinations of these fractures. The Trochanteric Long Nail System is additionally indicated to treat pertrochanteric fractures associated with shaft fractures, pathologic fractures in osteoporotic bone of the trochanteric and diaphyseal areas, long subtrochanteric fractures, ipsilateral femoral fractures, proximal or distal nonunions and malunions and revision procedures.
ACE Trochanteric Nail System STER TROC NAIL 180X13X140 STER TROC NAIL 125 DEG X 13MM STER TROC NAIL 130 DEG X 13MM STER TROC NAIL 135 DEG X 13MM The Trochanteric Nail System is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures and combinations of these fractures. The Trochanteric Long Nail System is additionally indicated to treat pertrochanteric fractures associated with shaft fractures, pathologic fractures in osteoporotic bone of the trochanteric and diaphyseal areas, long subtrochanteric fractures, ipsilateral femoral fractures, proximal or distal nonunions and malunions and revision procedures.
ACE Trochanteric Nail System TROCH NAIL ST 13X180 125DG STRL TROCH NAIL ST 13X180 130DG STRL TROCH NAIL ST 13X180 135DG STRL The Trochanteric Nail System is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures and combinations of these fractures. The Trochanteric Long Nail System is additionally indicated to treat pertrochanteric fractures associated with shaft fractures, pathologic fractures in osteoporotic bone of the trochanteric and diaphyseal areas, long subtrochanteric fractures, ipsilateral femoral fractures, proximal or distal nonunions and malunions and revision procedures.
ACE Trochanteric Nail System TROCH NAIL ST 11X180 125DG STRL TROCH NAIL ST 11X180 130DG STRL TROCH NAIL ST 11X180 135DG STRL The Trochanteric Nail System is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures and combinations of these fractures. The Trochanteric Long Nail System is additionally indicated to treat pertrochanteric fractures associated with shaft fractures, pathologic fractures in osteoporotic bone of the trochanteric and diaphyseal areas, long subtrochanteric fractures, ipsilateral femoral fractures, proximal or distal nonunions and malunions and revision procedures.
AIM Tibial Nails intramedullary fixation rod - NON-STERILE; Item numbers: 810508255 NAIL TIB DYN 08 X 25.5 810508270 NAIL TIB DYN 08 X 27.0 810508285 NAIL TIB DYN 08 X 28.5 810508300 NAIL TIB DYN 08 X 30.0 810508315 NAIL TIB DYN 08 X 31.5 810508330 NAIL TIB DYN 08 X 33.0 810508345 NAIL TIB DYN 08 X 34.5 810508360 NAIL TIB DYN 08 X 36.0 810508375 NAIL TIB DYN 08 X 37.5 810508390 NAIL TIB DYN 08 X 39.0 810508405 NAIL TIB DYN 08 X 40.5 810508420 NAIL TIB DYN 08 X 42.0 810509255 NAIL TIB DYN 09 X 25.5 810509270 NAIL TIB DYN 09 X 27.0 810509285 NAIL TIB DYN 09 X 28.5 810509300 NAIL TIB DYN 09 X 30.0 810509315 NAIL TIB DYN 09 X 31.5 810509330 NAIL TIB DYN 09 X 33.0 810509345 NAIL TIB DYN 09 X 34.5 810509360 NAIL TIB DYN 09 X 36.0 810509375 NAIL TIB DYN 09 X 37.5 810509390 NAIL TIB DYN 09 X 39.0 810509405 NAIL TIB DYN 09 X 40.5 810509420 NAIL TIB DYN 09 X 42.0 810510255 NAIL TIB DYN 10 X 25.5 810510270 NAIL TIB DYN 10 X 27.0 810510285 NAIL TIB DYN 10 X 28.5 810510300 NAIL TIB DYN 10 X 30.0 810510315 NAIL TIB DYN 10 X 31.5 810510330 NAIL TIB DYN 10 X 33.0 810510345 NAIL TIB DYN 10 X 34.5 810510360 NAIL TIB DYN 10 X 36.0 810510375 NAIL TIB DYN 10 X 37.5 810510390 NAIL TIB DYN 10 X 39.0 810510405 NAIL TIB DYN 10 X 40.5 810510420 NAIL TIB DYN 10 X 42.0 Product Usage: A metal rod which, when inserted into the intramedullary canal of the tibia, acts to immobilize by holding the ends of a fractured bone in position to promote healing. This device is non-sterile and must be sterilized prior to use. It is a single-use device.
AIM Tibial Nails intramedullary fixation rod - STERILE; Item numbers: 800508255 NAIL TIB DYN 08X25.5 - STERILE 800508270 NAIL TIB DYN 08X27.0 - STERILE 800508285 NAIL TIB DYN 08X28.5 - STERILE 800508300 NAIL TIB DYN 08X30.0 - STERILE 800508315 NAIL TIB DYN 08X31.5 - STERILE 800508330 NAIL TIB DYN 08X33.0 - STERILE 800508345 NAIL TIB DYN 08X34.5 - STERILE 800508360 NAIL TIB DYN 08X36.0 - STERILE 800508375 NAIL TIB DYN 08X37.5 - STERILE 800508390 NAIL TIB DYN 08X39.0 - STERILE 800508405 NAIL TIB DYN 08X40.5 - STERILE 800508420 NAIL TIB DYN 08X42.0 - STERILE 800509255 NAIL TIB DYN 09X25.5 - STERILE 800509270 NAIL TIB DYN 09X27.0 - STERILE 800509285 NAIL TIB DYN 09X28.5 - STERILE 800509300 NAIL TIB DYN 09X30.0 - STERILE 800509315 NAIL TIB DYN 09X31.5 - STERILE 800509330 NAIL TIB DYN 09X33.0 - STERILE 800509345 NAIL TIB DYN 09X34.5 - STERILE 800509360 NAIL TIB DYN 09X36.0 - STERILE 800509375 NAIL TIB DYN 09X37.5 - STERILE 800509390 NAIL TIB DYN 09X39.0 - STERILE 800509405 NAIL TIB DYN 09X40.5 - STERILE 800509420 NAIL TIB DYN 09X42.0 - STERILE 800510255 NAIL TIB DYN 10X25.5 - STERILE 800510270 NAIL TIB DYN 10X27.0 - STERILE 800510285 NAIL TIB DYN 10X28.5 - STERILE 800510300 NAIL TIB DYN 10X30.0 - STERILE 800510315 NAIL TIB DYN 10X31.5 - STERILE 800510330 NAIL TIB DYN 10X33.0 - STERILE 800510345 NAIL TIB DYN 10X34.5 - STERILE 800510360 NAIL TIB DYN 10X36.0 - STERILE 800510375 NAIL TIB DYN 10X37.5 - STERILE 800510390 NAIL TIB DYN 10X39.0 - STERILE 800510405 NAIL TIB DYN 10X40.5 - STERILE 800510420 NAIL TIB DYN 10X42.0 - STERILE 800511270 NAIL TIB DYN 11X27.0 - STERILE 800511285 NAIL TIB DYN 11X28.5 - STERILE 800511300 NAIL TIB DYN 11X30.0 - STERILE 800511330 NAIL TIB DYN 11X33.0 - STERILE 800511345 NAIL TIB DYN 11X34.5 - STERILE 800511360 NAIL TIB DYN 11X36.0 - STERILE 800511375 NAIL TIB DYN 11X37.5 - STERILE 800511390 NAIL TIB DYN 11X39.0 - STERILE 800511405 NAIL TIB DYN 11X40.5 - STERILE 800511420 NAIL TIB DYN 11X42.0 - STERILE 800512270 NAIL TIB DYN 12X27.0 - STERILE 8
Dimension Vista System LOCI 8 CALIBRATOR The LOCI 8 Calibrator is an in vitro diagnostic product for the calibration of follicle stimulating hormone (FSH), luteinizing hormone (LH), prolactin (PRL), and estradiol (E2) methods on the Dimension Vista System.
***STEVE'S REAL FOOD***RAW FROZEN DOG FOOD***TURKEY CANINE RECIPE***Distributed by: Steve's Real Food, Inc. Aumsville, OR***.
Intramedullary Brush Standard O.D. 14 mm, Product Number: 6198-001-514, UDI: (01)4546540255853 for orthopedic use.
Revolution 90 Degree Tibial Nozzle, Product Number: 0606-516-000, UDI: (01)4546540911971 for orthopedic use.
PCD Kit: Long 90, 13g Match-Ground w/ Bevel, Product Number: 0506-485-000, UDI: (01)4546540907035 for spinal orthopedic use.
180-Gram Cement Cartridge with Breakaway Femoral Nozzle, Product Number: 0206-530-000, UDI: (01)4546540857880 for orthopedic use.
10g/15mm (15/2) iVAS System Kit, Product Number: 0705-115-000, UDI: (01)7613252029830 for spinal orthopedic use.
1. InterPulse Handpiece with coaxial bone cleaning tip, Product Number: 0210-110-100, UDI: (01)4546540861641; 2. InterPulse Handpiece with Coaxial High Flow Tip, Product Number: 0210-114-100, UDI: (01)4546540861764; 3. InterPulse Handpiece with Retractable Coaxial Fan Spray Tip, Product Number: 0210-118-200, UDI: (01)4546540861818; 4. InterPulse Irrigation Only Handpiece with Fan Spray Tip, Product Number: 0210-218-000, UDI: (01)4546540144300 for orthopedic use.
Revolution CMS w/ Femoral Breakaway Nozzle & Med. Press., Product Number: 0606-573-000, UDI: (01)4546540912114 for orthopedic use.
1. AutoPlex System, Product Number: 0605-887-000, UDI: (01)4546540593108; 2. AutoPlex System: w/ VertaPlex HV, Product Number: 0607-687-000, UDI: (01)7613252039259 Bone cement.
1. 11g/10mm iVAS System Kit, Product Number: 0705-310-000, UDI: (01)7613252505983; 2. 11g/15mm iVAS System Kit, Product Number: 0705-315-000, UDI: (01)7613252505969 for spinal orthopedic use.
11g Verteport Cement Cannula (18/pkg), Product Number: 0306-511-000, UDI: (01)7613252594307 for spinal orthopedic use.
1. Femoral Canal Pressurizer without Hub, Medium, Blue, Product Number: 0206-546-000, UDI: (01)4546540039552; 2. Femoral Canal Pressurizer without Hub, Large, Red, Product Number: 0206-547-000, UDI: (01)4546540039569 for orthopedic use.
Break-Away Femoral Nozzle, Product Number: 0206-512-000, UDI: (01)4546540039415 for orthopedic use.
Advanced Cement Mixing (ACM) Kit w/ Femoral Breakaway Nozzle & Prox. Med. Press., Product Number: 0306-573-000, UDI: (01)4546540055415 for orthopedic use.
IDLife Snack Bar Chocolate and Almond (SKU 16-0011) Organic, non-GMO and gluten-free snack bar. Individually wrapped bars, packaged 10 to a box
IDLife Kids Bar Chocolate and Mixed Berry (SKU 16-0013) Organic, non-GMO, gluten-free and nut-free snack bar for children. Individually wrapped bars, packaged 10 to a box
IDLife Protein Bar Chocolate and Peanut Butter (SKU 16-0012) Organic, non-GMO and gluten-free protein bar. Individually wrapped bars, packaged 10 to a box
Gas Module 3 monitoring spirometer, Part Number: 115-030108-00 Product Usage: The Gas Module 3 is an accessory device designed to monitor airway gases during anesthesia and/or assisted respiration. Monitored gases includes O2, CO2, N2O and anesthetic agents Halothane, Isoflurane, Sevoflurane, Desflurane and Enflurane. It is intended for use in a fixed location such as the operating room or intensive care unit. The Gas Module 3 is compatible with Mindray patient monitors which display the gas analysis results through the use of a proprietary communication protocol.
Vital-Port Vascular Access System, Subcutaneous, implanted, intravascular infusion port and catheter, IP, IP-S, Product usage: The devices are intended for use in patient therapy requiring long-term vascular access for infusion therapy and/or blood sampling.
Tucker's Pork-Bison Formula, Raw Frozen, Complete & Balanced Formula, Dog Food for all life stages. 2 - 2-1/2 LB Pouches, Net Weight 5 LB (2.268 KG). UPC code 072635520017. Keep Frozen, Raw Basics, LLC, 10,000 80th Ave., Pleasant Prairie, WI 53158
Rotating IV Pole Rotating IV Pole falls under the category classified as capital equipment, an optional accessory that may be purchased to facilitate attachment and consolidation of patient equipment to one central patient care area. Devices commonly attached to IV poles include IV pumps, feeding pumps, and infusion fluid bags. Products used on: Giraffe OmniBed, Giraffe Warmers, Panda Warmers and Giraffe Incubators and Giraffe Shuttle. The IV pole also can be mounted to the Care Plus Incubator and Panda IWS.
Sonimage HS1 Ultrasound Kit AC adapter, Product Number: A8WA, UDI: 04560141944534
Sonimage HS1 Ultrasound Kit AC adapter, Product Number: 1. A9RP, UDI: 04560141945463; 2. AAEU, UDI: 04560141946385; 3. A9RR, UDI: 04560141945470
Sonimage HS1 Ultrasound Kit AC adapter, Product Number: A7AP, UDI: 04560141940031
Sonimage HS1 Ultrasound Kit AC adapter, Product Number: A8AR, UDI: 04560141941588
Echosight Jansen-Anderson Intratubal Transfer Set, Catalog Number: K-J-JITS-572900, Global Product Number: G17946 Product Usage: Used to place in vitro fertilized (IVF) embryos into the uterine cavity. Intended for one-time use
Norm-Ject Tuberkulin Syringe, Catalog Number: K-ATS-1000, Global Product Number: G19871 Product Usage: Used to place in vitro fertilized (IVF) embryos into the uterine cavity. Intended for one-time use
Marrs Laparoscopic GIFT Catheters, Catalog Number:K-J-MLC-503000, Global Product Number: G18022 Product Usage: Used to place in vitro fertilized (IVF) embryos into the uterine cavity. Intended for one-time use
Maurice's Honey Southern Gold BBQ Sauce; Net Wt. 18 oz. bottles; UPC Code 0 7561654332 6 and Carolina Gold Honey Sauce; Net Wt. 18 oz. bottle; UPC Code 0 7561654383 8
Extended Dwell Peripheral Catheter System, Catalog Numbers: EDC-00820 & EDC-00820-B
(1) Sigma HP Cemented Trochlea Size 1 Narrow Left, Catalog Number: 102403100, GTIN: 10603295001614; (2) Sigma HP Cemented Trochlea Size 2 Narrow Left, Catalog Number: 102403200, GTIN: 10603295001621; (3) Sigma HP Cemented Trochlea Size 3 Narrow Left, Catalog Number: 102403300, GTIN: 10603295001638; (4) Sigma HP Cemented Trochlea Size 4 Narrow Left, Catalog Number: 102403400, GTIN: 10603295001645; (5) Sigma HP Cemented Trochlea Size 5 Narrow Left, Catalog Number: 102403500, GTIN: 10603295001652; (6) Sigma HP Cemented Trochlea Size 1 Narrow Right, Catalog Number: 102404100, GTIN: 10603295001669; (7) Sigma HP Cemented Trochlea Size 2 Narrow Right, Catalog Number: 102404200, GTIN: 10603295001676; (8) Sigma HP Cemented Trochlea Size 3 Narrow Right, Catalog Number: 102404300, GTIN: 10603295001683; (9) Sigma HP Cemented Trochlea Size 4 Narrow Right, Catalog Number: 102404400, GTIN: 10603295001690; (10) Sigma HP Cemented Trochlea Size 5 Narrow Right, Catalog Number: 102404500, GTIN: 10603295001706
Red Zone Xtreme 3000 mg, capsules, Dietary Supplement, 1 count blister pack, UPC 8 91656 00200 9, Exp Date 12/31/2021
E-Z-Paste Barium Sulfate Esophageal Cream (60% w/w), 454 g tube, Rx only, Manufactured by E-Z-EM Canada Inc. for E-Z-EM Inc. a subsidiary of Bracco Diagnostics Inc., Monroe Twp., NJ 0883, NDC 32909-770-01
Technology, has applications in open and minimally invasive general abdominal, gynecological, pediatric, and thoracic surgery for resection, transection, and creation of anastomosis.
Dreyer's Slow Churned Vanilla Bean Ice Cream; 1.5 qt, (48-fl oz.); Lid is for Dreyer's Slow Churned Butter Pecan Ice Cream UPC 41548 00386
Phoenix Nail System, 3.5mm Inserter Connector, Short; Model Numbers: 14-441045, 14-440065S (kit) Accessory devices intended for use with an intramedullary nail system for alignment, stabilization and fixation of fractures.
IMRIS ORT300, Removable Operating Room Table, Part Numbers: (a) 114093-000 (b) 114093-600
Wegmans Avocado Summer Roll, 2 Pack, 5 oz. UPC: 2-48762-00000 or 2-48920-00000 packaged with Wegmans Thai Sweet Chili Sauce Cup 1.5 oz. (UPC 7-66630-98023)
Wegmans Assorted Gyoza (Dumplings), Family Pack, 17 oz. UPC: 2-48798-00000 or 2-48963-00000 packaged with Wegmans Thai Sweet Chili Sauce Cup 1.5 oz. (UPC7-66630-98023)
Wegmans Thai Sweet Chili Sauce Cup 1.5 oz. (UPC 7-66630-98023)
DATEX-OHMEDA AISYS CS2 ALADIN2 CASSETTE Cassettes are intended to be used to deliver anesthetic agent.
DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER Is designed for the metered delivery of specific inhalation anesthetic agents for use in continuous flow techniques of inhalation anesthesia.
Reloader 250 Mineral Bolus. A Vitamin-Mineral Bolus for Beef Cattle. For Ruminants only. 20 Boluses Net wt. 67 oz (1.9 kg), UPC 22304-44851, Twelve 20 count boxes / carton. 40 Boluses Net wt. 134 oz (3.8 kg) UPC 22304-44850, Six 40 count boxes / carton. Manufactured for: Provimi North America, Inc., Brookville, Ohio 45309
1.5 oz. cup with seal on label reading: Thai Sweet Chili Sauce; Ingredients: Thai Sweet Chili Sauce (Sugar, Water, Pickled Red Chili, Vinegar, Garlic, Salt, Xanthan Gum); Net Wt. 1.5 oz.; coded: BB 07/04/18, BB 07/05/18
Syngo.via software is intended to be used for viewing, manipulation, communication, and storage of medical images. It can be used as a standalone device or together with a variety of cleared and unmodified syngo based software options.
Vancomycin 1g added to 250mL of 0.9% Sodium Chloride IV bag, Rx only, APOLLOcare, 3801 Mojave Ct., Suite 101, Columbia, MO 65202, NDC 71170-254-25.
Vancomycin 1.25g added to 250 mL of 0.9% Sodium Chloride IV bag, Rx only, APOLLOcare, 3801 Mojave Ct., Suite 101, Columbia, MO 65202, NDC 71170-254-25.
diet pepsi caffeine free Classic Diet Pepsi Taste, 12 FL OZ (355 mL), UPC: 0 12000 17230 4
Southgate Hot Dog Chili Sauce 15 oz cans UPC 0 71846 95242
HEMASHIELD Knitted Double Velour Cardiovascular Fabric
Product Name Lot Number or ID Roasted Wing Marinade Seasoning 661107
Product Name Lot Number or ID Whiskey & Cola Type Flavored Seasoning 660373
Product Name Lot Number or ID Premix Roasted Chicken 1258969 660025
Product Name Lot Number or ID Salt & Vinegar Seasoning - 50 LB CS 662977
Product Name Lot Number or ID Toasted Italian Herbs 661126
Product Name Lot Number or ID Pan Roast Brown Gravy Mix 659281, 659282, 659283, 659284, 659285, 659286 Pan Roast Brown Gravy Mix 661090, 661089, 661091
Product Name Lot Number or ID Fire Roasted Steak Type Seasoning 655697
Product Name Lot Number or ID Au Jus Seasoning Reduced Sodium 659868, 660660, 660661, 660662, 660663 Au Jus Seasoning Reduced Sodium 656387, 656388, 659864, 659865, 659866, 659867
Roast Chicken Marinade SE746125 and SE746126, 50# Bags
Au Jus Seasoning BM652767; bulk 50 lb boxes
Bourbon Brown Sugar Rub SE746665, 50# Bags
Roast Grill Seasoning SE746664, 50# Bags
Proclaim DRG Implantable Pulse Generator, Model Number 3664
Diced Yellow Onion 4/5# bags - 20 lb, corrugated paper carton; 20 lb. box for food service distribution. Item number 1130025; Taylor Farms California Foodservice; Salinas, CA
ACUSON SC2000 Ultrasound System. The firm name on the label is Siemens Medical Solutions USA, Inc., Buffalo Grove, IL.
Indomethacin Capsules USP, 50 mg, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Colvale-Bardez, Goa 403513, India; Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-302-01.
J.M. Rosen's Cheesecake - Fantasy; 9 - Unit- 64 Slices in a case box; Product #55993 UPC 6 89076 70759 6; INGREDIENTS: Cream Cheese (Pasteurized Milk. and Cream, Cheese Culture, Salt, ( Stabilizers (Xanthan Gum, and/or Carob Bean Gum, and/or Guar Gum), Unbleached flour, (unbleached Wheat Flour, Thiamine Mono-nitrate, Niacin, Iron, , Riboflavin. Folic Acid, Malted barley, flour) Granulated Sugar, Eggs, unsalted Butter (Cream (Milk)), Sour Cream (Milk. - Enzymes), Cream, milk, Orange and Lemon Rind, NielsonMasseyVanilla), Chocolate layer cake sour cream, Unbleached Flour. Dark brown sugar, Eggs, Water, Butter, Chocolate (Cocoa Bean, Sugar; Soy Lecithin, Pure Vanilla, Soybean Oil, Cocoa Powder, Baking powder, baking soda, Vanilla Extract, Chocolate Mousse (Cream, Water, Powdered Sugar, Cocoa Powder; Gelatin, Mousse Base{Sugar; Cocoa Powder, Dextrose, Gelatin, Salt), Chocolate. Ganache (Cacao Bean, Sugar, Soy lecithin Vanilla), Dark Chocolate Topping (Cocoa Mass, sugar, cocoa butter, Milkfat, Soy Lecithin Natural Vanilla Contains: Eggs, Milk, Wheat
J.M. Rosen's Cheesecake - New York Traditional; 6 - Unit- 4/46 oz in a case box; Product #56378 UPC 6 93892 99462 7; INGREDIENTS: Cream Cheese (Pasteurized Nonfat Milk, and Milkfat~ Whey Protein Concentrate, Cheese Culture. Salt, Whey, Stabilizers (Xanthan Gum, and/or Carob Bean Gum, and/or Guar Gum)}, Unbleached Flour, (Unbleached Wheat Flour, Thiamine Mono-nitrate, Niacin. Iron, Riboflavin, Folic Acid, Malted Barley Flour), Granulated Sugar Cane, Eggs, Unsalted Butter (Cream {Milk)), Sour Cream (Milk, Enzymes). Cream {Milk), Orange and Lemon Rind, Nielson Massey Vanilla).
Cole Slaw, Store Made. Packed in deli-style plastic containers: Weis, Weis Markets, Inc., Sunbury, PA; Cabbage, Carrots, Pineapple, White Onions, Sugar, Salt Pepper, Vinegar, Hellmanns Mayonnaise
Fosphenytoin Sodium Injection, USP 500 mg PE*/10 mL, Made in India. Distributed by: Amneal Biosciences, Bridgewater, NJ 08807, NDC 70121-1390-1
F-T3SYSTEM, T3 (Trumpf Table Top) System The device is a surgical table accessory system used to allow prone positioning on OR table tops during spinal surgery. The system consists of a table top frame, arm supports,
24-HOUR Oral Care q2 Kit with Ballard* Technology, containing 2 Toothbrush Packs with CHG Solution, Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL unit dose cup (NDC 50383-720-15), Rx Only, Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701; Kit Manufactured by Halyard Health, Inc., 5405 Windward Parkway, Alpharetta, GA 30004; Distributed in the USA by Halyard Sales, LLC, Alpharetta, GA 30004, Product 97012.
24-HOUR Oral Care q4 Kit with Ballard* Technology, containing 2 Toothbrush Packs with CHG Solution, Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL unit dose cup (NDC 50383-720-15), Rx Only, Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701; Kit Manufactured by Halyard Health, Inc., 5405 Windward Parkway, Alpharetta, GA 30004; Distributed in the USA by Halyard Sales, LLC, Alpharetta, GA 30004, Product 97014.
Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL unit dose cups (NDC 50383-720-15) packaged in 100-count (10 x 10) cups per case pack (NDC 50383-720-18 or 50383-720-19), Rx Only, Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701.
diet Pepsi Classic Diet Pepsi Taste, 12oz cans, sold as a 12 pk, ambient storage.

Product Quantity
Approx. 1418 cases (12 bottles/case); approx. 17,016 bottles total
194 Diet Pepsi Caffeine Free 8 pack cases

Reason for Recall
Patient results determined using this calibrator lot might deviate up to 20%. Controls might not indicate false values.
Two lots of the Tapered Screw-Vent Implants, with different outer thread diameters, were inadvertently commingled during the manufacturing process and may be mislabeled.
Increased amount of residual blood present on the top of stopper well after venipuncture
Complaints have been received concerning questionable results on analyzers due to customers utilizing 13 sample tubes without tube adapters.
Complaints have been received concerning questionable results on analyzers due to customers utilizing 13 mm sample tubes without tube adapters.
Complaints have been received concerning questionable results on analyzers due to customers utilizing sample 13 mm tubes without tube adapters.
Some contact lenses were associated with complaints of a foreign matter caught between the blister package and foil.
It was discovered during a surgery that the design of the radius at the base of the pegs of the Anatomic Glenoid Trial (Part Numbers: 804-07-380, 804-07-420, 804-07-460, 804-07-500, and 804-07-540) is much larger on the trails than on the implants
The calibration for the affected batch of analyzers was incorrectly set during the manufacturing process which may lead to a failure when calibration is first performed. There may also be e remote possibility that incorrect qualitative test results for patient samples near the assay cutoff may be reported.
A locking plastic abutment sleeve, used by dental technicians in dental laboratories to aid in the creation of the final restorative crown, was packed as a non-locking plastic abutment sleeve.
Some boxes are labeled as Visistat Wide devices, when in fact the contain Visistat Regular devices. The 6 individually packaged units within the boxes are correctly labeled.
Superpotent and Failed Stability Specifications; out of specification results for assay and water vapor permeability
Coconut is listed in the ingredient statement but is not declared in the Contains statement
Defective Delivery System: Potential that cracks in the vial neck near the crimp may result in product evaporation and/or leaking and the inability to properly dispense product.
Wire sets of certain devices were assembled with adhesive on the contact wires, which may impede conductivity and could cause failure
Broken or missing screws and retaining clips. This may be due to screw tolerance and material strength of the trial.
The rotational locking mechanisms on the ORT 200/300 tables fail to operate such that it cannot change states between locked and unlocked.
Rechargeable lithium-ion batteries with incorrect firmware that are used in certain Puritan Bennett 980 ventilators may not fully charge after installation.
The concentration of bromocresol purple in the recalled lots does not conform to specification.
The cobas MRSA/SA tests may have decreased performance compared to the analytical sensitivity for MSRA detection. A screening failure can lead to potential infection in the colonized patient being tested as well as the spread of MSRA to others. The United States is not impacted, as the cobas MRSA/SA nucleic acid test for use on the cobas liat system is not available in the US.
This Correction is being initiated based on a customer complaint received on November 16, 2017 which indicated a complication with a cataract procedure. An investigation completed by the manufacturer determined that although the complication was due to user error improvements could and should be made on our part to improve the usability and performance of our device.
The device power supply was not manufactured according to specification which can result in the loss of the protective grounding of the instrument.
Certain partial knee implant spacer blocks do not fit in the alignment tower instrument or handle.
A complaint was received for Item 42-5320-067-02, lot 63236047. It was report that there was no set screw or taper plug included in the box. Complaint investigation confirmed that the entire lot of 63236047 was missing the set screw and taper plug.
Zimmer Biomet is conducting a medical device recall for the Persona Partial Knee Spacer Blocks in sizes 8mm, 9mm, 10mm, 12mm, and 14mm. Complaints received indicated that flexion has the potential to feel tight during range-of-motion trialing and that the final trial has the potential to appear looser in extension.
Zimmer Biomet received reports that during assembly, an SRS Humeral Distal Body implant failed to engage correctly at the point of reduction with a Discovery Elbow System Humeral Condyle. A mismatch occurred between the screw holes in the Distal Humeral Body & the Discovery Elbow Condyle implant during vendor machine operation. The condition would be noticed during assembly and therefore, if the product has already been implanted, no further action is required. The mismatch does not always prevent engagement of the screw, based on complaints received it is estimated to prevent engagement of the screw in less than 1% of cases.
One lot of humeral stem implants do not include the humeral bushing components.
Affected lots may have exceeded its microbial limits.
Certain packages labeled as size 7.5 Extended Offset Reduced Neck length hip implant, actually contained a Size 4 Standard Reduced Neck length taper hip implant.
Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system after a Device Performance Review (DPR) failed clinical analysis for survivorship pursuant to the acceptance criteria for the DPR protocol for the ATN system.
The AIM Tibial Nails failed a clinical analysis where the surgical revision rate exceeded the acceptance criteria in the Device Performance Review protocol for the implant system.
An increase in the number of failed calibration events or negative bias with Quality Control (QC) and patient samples when using Dimension Vista LOCI 8 Calibrator lot 7CD076 to calibrate Estradiol (E2) Assay.
One lot of Raw Frozen Dog Food Turkey Canine Recipe, 5 lb. packages, is recalled due to potential to be contaminated with Salmonella.
Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.
IDLife Snack Bars contain almonds but do not declare the presence of peanuts.
IDLife Kids Bar is labeled as nut free. Allergen testing indicated the presence of almonds and coconut.
IDLife Protein Bars contain peanuts but do not declare the presence of almonds.
The firm made multiple changes to the product requiring the submission of a new 510(k) premarket notification.
Product has the potential to be contaminated with Salmonella.
The kit was packaged with the incorrect guidewire. The label indicates the kit contains a marked guidewire. The kits were packaged with an unmarked guidewire.
Complaints regarding 6F Taiga guide catheter tip detachment and/or tip splitting.
There is the potential for the Rotating IV Pole to fall. A fall could result in an injury to a bystander holding the patient or to the operator.
There is a risk of circuit board breakage within the main housing of the AC Adapter unit. Smoke may be emitted from the AC Adapter as a direct result.
Mushroom Condensed Soup, packaged in glass pint Kerr jars, is recalled due to under-processed or the venting schedule was not followed.
Certain lots of in vitro fertilization (IVF) products were distributed without completed finished device quality testing with potential adverse events that may include nonviable gametes and/or nonviable embryos.
Certain lots of peripheral catheter systems may be missing the safety latch, intended to minimize the risk of sharps injuries.
Marketed without an Approved NDA/ANDA; FDA analysis found this product to contain undeclared Tadalafil, an FDA approved drug for the treatment of erectile dysfunction.
Failed stability specifications: Out-of-specification (OOS) result for a preservative assay - methylparaben - during stability testing of one lot.
Product reportedly shutting down during use.
Sales Team employee noticed that some cartons of 48-fl oz. cartons of Dreyers Slow Churned Vanilla Bean Ice Cream contain Butter Pecan ice cream an have a Dreyers Slow Churned Butter Pecan lid.
Certain lots of the Phoenix Tibia Nail 3.5mm Inserter instruments are being recalled due to reports of fracturing and remaining in the device implant.
The Operating Room Table may drift while in use, which could potentially result in unintended movement of the table.
The product is labeled as Thai Chili Sauce. The product actually contains Spicy Sauce which contains undeclared egg.
Non-Conforming devices were shipped from the service center without proper evaluation and therefore may be nonconforming.
Gourmet Cream Cheese Cinnamon Roll is recalled due to undeclared egg.
The Reloader 250 Mineral Bolus may result in potentially releasing less vitamins and minerals per day than what the label states.
The firm received a report that 3 cups labeled as Spicy Mayonnaise Sauce was labeled as Thai Sweet Chili Sauce
must be manually prevented from being deleted by either clinical administrator or service engineer.
Stability Data Does Not Support Expiry: 90-day beyond use date (BUD) for the affected product is not supported.
Primary package is properly labeled with Aspartame containing liquid but the outer wrap states Aspartame Free.
The firm was notified by a customer that the product contains Dumplings with Chicken. The Dumplings with Chicken contains egg and wheat which are not listed on the label.
A probable mislabeling of the product: a different-sized product is referenced on the product packaging label (i.e. 2.5 cm (width) x 7.6 cm (length)) while the actual product inside the box is 2.5 cm (width) x 15 cm (length).
Mondelez Global LLC is initiating a recall because remnants of a half peanut shell were found in two containers of bulk candy from a single lot during the repacking process and the candy is not labeled as containing peanuts. Mondelez Global LLC after an investigation, including inspection of product within in their control from the same lot did not find any other evidence of peanut contamination. The firm believes this is most likely to be an isolated incident and that product on the market is unlikely to contain any peanut pieces and the product is not likely to cause adverse health consequences to peanut allergic consumers. No adverse health events have been reported. Never the less, out of an abundance of caution, we have determined to conduct a voluntary recall to the retail level.
Griffith Foods, Inc. has initiated a voluntary recall of multiple products following a supplier's recall of Autolyzed Yeast Powder due to the presence of Salmonella.
Newly Weds Foods, Inc. initiated a voluntary recall of dry blended seasonings for industrial use due to a supplier's recall of yeast because of the presence of salmonella.
The firm received complaints of error messages that occurred during routine impedance checks on Proclaim DRG IPGs, model 3664. Some complaints were also associated with transient over stimulation which created discomfort for the patients.
Firm was notified by direct customer of a confirmed positive result for Salmonella ssp. after routine testing of the diced onion product.
The ECG signal may flatline due to electromagnetic interference during the use of electrosurgical equipment.
Retail store employee noticed a small rubber object in the cheesecake - the firm is recalling the entire day's production.
Software issue with Center Beam in Field functionality. Issue can result in incorrect treatment volume delivered to patient.
The ingredient label failed to declare egg because the store-made coleslaw scale label did not list the sub-ingredients of mayonnaise.
The recalling firm has become aware that the rail section clamps used to attach the leg support of the device may fail during use, which could result in critical harm to the patient.
Subpotent Drug: Product crystallization with accompanying low out of specification results for chlorhexidine assay.
PepsiCo is recalling Diet Pepsi due to mislabeling.

Code Info
Lot B00DHLP Exp. 08/2018 Base Curve 8.7, Refractive Power -10.00D - Manufactured in J&J Vision Care Inc. Jacksonville, FL Lot L002FNL Exp. 07/2020 Base Curve 8.7 Refractive Power -4.75D Manufactured in J&J Vision Care Ireland Lot L002V94 Exp. 01/2022 Base Curve 8.7 Refractive Power -5.00D
Lot L002NCS exp. 05/2020 base Curve 8.8 Refractive Power -4.00D and Lot L002QH9 exp. 08/2020 Base Curve 8.8 Refractive Power -4.50D Manufactured at J&J Vision Care Ireland
Lot B00LF41 Exp. 04/2021 Base Curve 8.5 Refractive Power -7.50D -1.25/180 Manufactured at J&J Vision Care Inc. Jacksonville, FL
VP6 47 through VP6 53 (Fresh Case) W VP6 47 through W VP6 53 (Grab and Go)
(Grab and Go) W-HC47 through WHC53; (Fresh Case) HC47 through HC53
Lot #s: 70712A (6 kits); 70601W (76 kits); 70713A (4 kits); 70718A (50 kits); and 70809A (kits were not distributed to end users).
EP-4 Lots EXP20 l 7 l 209A, EXP20 l 80512A; and EP-4D Lot EXP20 l80520A
All Gas Modules 3 with Part Number 115-030108-00 purchased between February 14, 2008 and October 2015.
Lot/Serial/Model/Catalog Numbers/Exp. Date: Lot # MJKK420; serial # N/A, Catalog # MRDP80PLN, Exp. Date 2022-01-09; UDI#- 884908110449
Model Number(s): 6600-0851-800 Affected lot codes are within LAU13921134 - LAU14720444
1. Catalog Number: K-J-SMS-571800, Lot Number: 6802704, Expiration Date: 3/10/2019; 2. Catalog Number: K-JETS-551910-L, Lot Number: NS6360603, Expiration Date: 11/15/2018; 3. Catalog Number: K-JETS-7019-SIVF, Lot Number: 6503675, Expiration Date: 2/2/2019
Lot Number: 7131328, Expiration Date: 7/19/2019
Lot Number: 5571684, Expiration Date: 1/12/2018
Catalog Number: EDC-00820, Lot: 14X17C0039 (Expires February 2019); Catalog Number: EDC-00820-B, Lot: 13F17F0120 (Expires May 2019)
manufacturing code 7335580502; best by date of 02SEP2018
Model 1100-9034-000 Mfg. Lot or Serial # BGBQ00675 and BGBQ01187
All Syngo.via systems with VB20A. Model number 10496180.
Retail UPC; Number of Retail Units 0 70462 43309 8; / 1 Retail Unit Case UPC; Units Per Case 0 00 70462 00043 6; / 4 Units per Case
Date Manufactured, Finished Product #, Product Description, and NWF Product Lot Code 2/21/2018 G68565 Roast Chicken Marinade SE746125 2/21/2018 G68565 Roast Chicken Marinade SE746126
Date Manufactured, Finished Product #, Product Description, and NWF Product Lot Code 2/8/2018 G51631 Au Jus Seasoning BM652767
Date Manufactured, Finished Product #, Product Description, and NWF Product Lot Code 2/21/2018 G96452 Bourbon Brown Sugar RubSE746665
Date Manufactured, Finished Product #, Product Description, and NWF Product Lot Code 2/9/2018 I46008 Lbs, flv roast dark type BM654892
Date Manufactured, Finished Product #, Product Description, and NWF Product Lot Code 2/21/2018 G92287 Roast Grill Seasoning SE746664
Lot Number 6210849 Serial Number AVM174.1 Lot Number 6210852 Serial Numbers: AVA560.1, AVA214.1, AVL027.1 Lot Number 6499208 Serial Numbers: AVD426.1, AVA922.1 Lot Number 6263128 Serial Numbers: AVB119.1, AVD400.1, AVA622.1, AVD431.1, AVE633.1, AVK678.1, AVN837.1 Lot Number 6268723 Serial Numbers: AUV770.1, AVW805.1 Lot Number 6278155 Serial Number AVK896.1
Package code: STF066A56; Best if used by March 24, 2018.
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