Recalling Firm
Philips Electronics North America Corporation
Blood Bank Of San Bernardino And Riverside Counties
Mindray DS USA, Inc. dba Mindray North America
Fresenius Medical Care Renal Therapies Group, LLC

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

Distribution Pattern
Worldwide Distribution -- USA, including the states of AZ, CA, CO, FL, GA, HI, IL, IN, KY, MA, MI, MN, MO, MT, NC, ND, NE, NV, OH, OK, PA, SC, SD, TN, TX, UT, VA, VT, and WA; and, the countries of Algeria, Angola, Argentina, Armenia, Australia, Austria, Austria, Azerbaijan, Bangladesh, Belarus, Belgian, Bolivia, Brazil, Bulgaria, Bulgaria, Cambodia, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czechia, Denmark, Dominican. Rep., Ecuador, Egypt, El Salvador, Estland, Finland, France, Gabon, Germany, Greece, Guatemala, Holland, Honduras, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Kuwait, Latvia, Lebanon, Libya, Lithuania, Malaysia, Maldives, Mauritius, Macedonia, Mexico, Mongolia, Morocco, Myanmar, Nepal, New Zealand, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Rwanda, Saudi Arabia, Scotland, Serbia, Seychelles, Slovakia, Slovenia, South Africa, Spain, SRI Lanka, Sudan, Suriname, Sweden, Sweden, Switzerland, Syria, Taiwan, Tajikistan, Thailand, Trinidad & Tobago, Tunisia, Turkey, UAE, Uganda, UK , Ukraine, Uruguay, Venezuela, Vietnam, and Yemen.
Worldwide Distribution: US (nationwide) to state in AZ, CA, CO, FL, SC, and TX; and countries of: Canada and Japan.
United States: nationwide, including Puerto Rico; and Foreign: Canada, Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Bermuda, Bolivia, Brazil, Brunei Darussalam, Chile, China, Colombia, Croatia, Czech Republic, Ecuador, France, Germany, Greece, Guadeloupe, Guatemala, Hong Kong, Hungary, India, Indonesia, Iraq, Israel, Italy, Japan, Kenya, Korea, Kuwait, Lebanon, Lithuania, Macao, Macedonia, Malaysia, Maldives, Martinique, Mexico, Moldova, Republic Of, Montenegro, Morocco, Netherlands, New Zealand, Nigeria, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, U.A.E, Uganda, United Kingdom, United States, Uruguay, Venezuela, Vietnam
Distribution was made nationwide in the U.S. and in Puerto Rico. There was also government distribution, but no military distribution. Foreign distribution was made to Angola, Australia, Belgium, Botswana, Brazil, Canada, Chile, Colombia, Czech Republic, Denmark, Finland, France, Germany, Ghana, Hong Kong, India, Israel, Italy, Japan, Kazakhstan, Kenya, Lesotho, Malawi, Malaysia, Mexico, Namibia, Netherlands, New Zealand, Norway, Pakistan, Panama, Poland, Portugal, Romania, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Uganda, Ukraine, United Kingdom, and Zambia.
Distributors were notified via letter. Lot 5430 was not distributed in the US. Lot 5178 was also affected by this issue, but this lot expired on 31-Mar-2017 so Ortho took no action on this lot.
Distributed in all 50 U.S. states and the District of Columbia. Distributed in Bahamas, Canada, Mexico, Panama, and Singapore.
Worldwide distribution. US nationwide, Canada, Chile, Colombia, Costa Rica, France, Hong Kong, Israel, Jamaica, Japan, Jordan, Malaysia, Mexico, Oman, Panama, Russian Federation, Saudi Arabia, Singapore, Spain, Taiwan, UAE, and UK.
US Distribution to the states of : AL, OH, VA, NC, GA, NY, FL
Distribution US Nationwide, Canada, India, and Colombia.
NM, MI, and TX EU, Australia, Japan, and Hong Kong
Distributed domestically to AK, AL, AR, CA, CO, DE, FL, GA, ID, IL, IN, MD, MI, MO, MT, NM, NY, OH, OK, PA, SC, TN, TX, VA, WA, WV.
US Distribution including Puerto Rico and to the states of : CA, MI, NC, TX, and WA. .
The devices were distributed in California.
US Nationwide Distribution in the states of AR, CA, GA, KS, MA, MD, MO, NC, NJ, NW, NY, TX and Hawaii
Worldwide Distribution: US (nationwide) to states of: AR, AZ, CA, CO, FL, ID, IA, KS, KY, ME, MO, NE, NY, OR, TN, TX, UT, and WA; and countries of: Argentina, Australia, Austria, Belgium, Bolivia, Brazil, Cameroon, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, Germany, Ghana, Hong Kong, Hungary, India, Iran, Iraq, Italy, Japan, Jordan, Kenya, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Namibia, Netherlands, Nigeria, Oman, Pakistan, Panama, Paraguay, Poland, Portugal, South Korea, Romania, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Trinidad-Tobago, Turkey, UAE, UK, Yemen and Zimbabwe.
Worldwide Distribution - USA(nationwide) Distribution to the states of : NJ, CA, OH, VA, MA, MN, IL , UT, TN, AR, LA, AZ, PA, TX, IA and HI., and to the countries of : Costa Rica, Jamaica, South Africa, New Zealand, South Korea, Dubai, Saudi Arabia and Jordan.
Internet sales directly to 350 customers. For foreign/VA/govt/military accounts.
U.S. consignees and one (1) foreign consignee.
US Nationwide Distribution in the states of NE, KY, CA, OH, TX, NC, AL, NJ, TN, MN, IA, MO, MA, MI, ME, BY, GA, WA, LA, IL, VA, NY
AL, AZ, CA, CO, DE, FL, GA, IA, IL, IN, KY, LA, MI, MS, NC, NH, NY, OH, OR, PA, TN, TX, UT, VA, WI
Distributed in CA, FL, MI, ND, NH, NY, OH, OR, TX, and WA and in Mexico and United Arab Emirates.

Product Description
Hamilton-C3 Ventilator Unit Intended to provide ventilator support to adults and pediatrics and optionally infants and neonates in the hospital.
Hamilton-C2 Ventilator Unit Intended to provide ventilator support to adults and pediatrics and optionally infants and neonates in the hospital.
HomeSafe AutoAlert Pendant works in conjunction with a compatible Lifeline communicator.
Hex Driver Part Number HXDRIVER-2.0 AO; Hex Driver Part Number HXDRIVR-2.5 AO; Hex Driver Part Number HXDRIVR-2.5CL AO; Hex Driver Part Number DVHX-2.5/130C AO; Hex Driver Part Number HXDRIVR-3.0 AO; Hex Driver Part Number HXDRIVER-3.5AO
Apheresis Platelets, Leukocytes Reduced, Irradiated
AQUIOS CL Flow Cytometer System, Catalog #B30166. The AQUIOS CL Flow Cytometer system is an automated analyzer that use a no-wash sample preparation process.The firm name on the label is Beckman Coulter Ireland, Inc., Co. Clare, Ireland.
Blood and Blood Products for Reprocessing
Wild Meadow Raw Goat Milk Cheese. The product is packaged in various sizes of sealed flexible plastic packaging, displaying the plant number 36-1315.
Normed Charcot Osteotome Chisel (Various sizes)
ORTHOFIX, Connector System, LARGE SET SCREW, REF 79-2002
ORTHOFIX, Connector System, SMALL SET SCREW, REF 79-2003
Bard(R) Premature Infant Feeding tube, ENFit(TM), REF EN0036430 Product Usage: BARD(R) Nasogastric Sump Tubes with ENFit(TM) connector are intended to be used for: Decompression of stomach by suction or aspiration of gastric contents Short-term administration of term tube feeding, lavage fluid and medications Feeding Tubes with the ENFit(TM) Connector are made of a smooth plastic with a two-eyed tube used for nasogastric feeding of neonates, infants and adults as well as diagnostic and therapeutic aspiration. These products are sold single-use, sterile. The Feeding Tube with the ENFit(TM) connector provides a way to reduce the risk of enteral device misconnections. The ENFit(TM) connector: Addresses patient side connections between feeding tubes, administration sets, medication, flush and bolus feeding syringes, and other enteral devices. Does not allow connectivity with any other connector for any other clinical use.
Bard(R) Premature Infant Feeding Tube, ENFit(TM), REF EN0036400 Product Usage: BARD(R) Nasogastric Sump Tubes with ENFit(TM) connector are intended to be used for: Decompression of stomach by suction or aspiration of gastric contents Short-term administration of term tube feeding, lavage fluid and medications Feeding Tubes with the ENFit(TM) Connector are made of a smooth plastic with a two-eyed tube used for nasogastric feeding of neonates, infants and adults as well as diagnostic and therapeutic aspiration. These products are sold single-use, sterile. The Feeding Tube with the ENFit(TM) connector provides a way to reduce the risk of enteral device misconnections. The ENFit(TM) connector: Addresses patient side connections between feeding tubes, administration sets, medication, flush and bolus feeding syringes, and other enteral devices. Does not allow connectivity with any other connector for any other clinical use.
Bard(R) Adult/Pediatric Feeding Tube, ENFit(TM), REF EN0036420 Product Usage: BARD(R) Nasogastric Sump Tubes with ENFit(TM) connector are intended to be used for: Decompression of stomach by suction or aspiration of gastric contents Short-term administration of term tube feeding, lavage fluid and medications Feeding Tubes with the ENFit(TM) Connector are made of a smooth plastic with a two-eyed tube used for nasogastric feeding of neonates, infants and adults as well as diagnostic and therapeutic aspiration. These products are sold single-use, sterile. The Feeding Tube with the ENFit(TM) connector provides a way to reduce the risk of enteral device misconnections. The ENFit(TM) connector: Addresses patient side connections between feeding tubes, administration sets, medication, flush and bolus feeding syringes, and other enteral devices. Does not allow connectivity with any other connector for any other clinical use.
Bard(R) Infant Feeding Tube, ENFit(TM), REF EN0036410 Product Usage: BARD(R) Nasogastric Sump Tubes with ENFit(TM) connector are intended to be used for: Decompression of stomach by suction or aspiration of gastric contents Short-term administration of term tube feeding, lavage fluid and medications Feeding Tubes with the ENFit(TM) Connector are made of a smooth plastic with a two-eyed tube used for nasogastric feeding of neonates, infants and adults as well as diagnostic and therapeutic aspiration. These products are sold single-use, sterile. The Feeding Tube with the ENFit(TM) connector provides a way to reduce the risk of enteral device misconnections. The ENFit(TM) connector: Addresses patient side connections between feeding tubes, administration sets, medication, flush and bolus feeding syringes, and other enteral devices. Does not allow connectivity with any other connector for any other clinical use.
VITROS Immunodiagnostic Products TSH Reagent Pack
Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard Technology, Part Numbers: (1) ASK-45541-RWJ4; (2) ASK-45552-RWJ4
(1) Central Venous Catheterization Kit, Part Number (PN): ASK-04300-PHP; (2) Single-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter, PN: ASK-04301-WBH; (3) Vessel Catheterization Kit, PN: ASK-04550-NYP
Multi-Lumen Hemodialysis Catheterization Kit for High Volume Infusions, Part Number: CDC-12123-P1A
(1) Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Features, and Maximal Barrier Precautions for use with 7.5 - 8 Fr. Catheters, Part Number: ASK-09803-WBH1; (2) Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Features, and Maximal Barrier Precautions for use with 7.5 - 8 Fr. Catheters, Part Number: ASK-09903-KH; (3) Percutaneous Sheath Introducer Kit for use with 7.5 - 8 Fr. Catheters, Part Number: ASK-09903-LC; (4) PSI Kit for use with 7.5 - 8 Fr. Catheters, Part Number: ASK-09903-PHP; (5) Percutaneous Sheath Introducer Kit for use with 7.5 - 8 Fr. Catheters, Part Number: ASK-09907-LGH1; (6) Arrow PSI Kit, Part Number: CDC-09803-1A; (7) Arrow PSI Kit, Part Number: CDC-09903-1A
Arrowg+ard Blue(R) PSI Kit, (1) For use with 7 - 7.5 Fr. Catheters Part Number (PN): ASK-29804-UHN2; (2) For use with 7.5 - 8 Fr. Catheters PN: ASK-29903-UCD
(1) Arterial Catheterization Kit, Part Number (PN): ASK-04018-CC; (2) Arterial Line Kit with Sharps Safety Features, PN: ASK-04510-HUM; (3) Arterial Line Kit with Sharps Safety Features, PN: ASK-04550-UHC; (4) Arterial Catheterization Kit, PN: NA-04550-X1A
AGB+ Multi Lumen CVC Kit (1) Part Number (PN): CDC-42703-B1A, (2) PN: CDC-42802-1A, (3) CDC-45703-1A, (4) CDC-45703-A1A, (5) PN: CDC-45703-B1A; AGB+ Quad-Lumen CVC Kit (6) PN: CDC-42854-1A, (7) PN: CDC-45854-1A; AGB+ Two-Lumen CVC Kit (8) PN: CDC-45802-1A, (9) PN: CDC-45802-B1A, (10) PN: CDC-46702-1A, (11) CDC-47702-1A; (12) Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features, PN: ASK-45703-AH
Two- Lumen Central Venous Access Kit, Product Number: CDC-11242-1A
(1) Access Tray, Part Number (PN): ASK-04001-MS; Arrow Multi-Lumen CVC Kit (2) PN: CDC-12703-1A; (3) PN: CDC-15703-1A; (4) PN: CDC-15703-B1A; Arrow Two-Lumen CVC Kit (5) PN: CDC-12802-1A; (6) PN: CDC-15802-1A; (7) PN: CDC-17702-1A
D-RAD Self-Tapping Locking Screw intended for the fixation of fractures involving the distal radius. smith&nephew D-RAD 2.4MM X 10MM S-T LOCKING SCREW, REF 74692410, QTY (1), STERILE R
Progressa Bed - AC-powered adjustable hospital bed
Foot Controls Model: S-N1 and S-N2 Product Usage: Variable foot control for use with drive units operating mechanical instruments.
LOST CAJUN GUMBO BASE, T4014, PACK SIZE 45 lb bag, Blended by ALL AMERICAN SEASONINGS, 10600 E. 54th Ave., Units B & C, Denver, CO 80239
PDS Plus Antibacterial (Polydioxanone) Suture Size 0 PDS Plus Violet 36 Single Armed CTB-1 Needle
PDS Plus Antibacterial (Polydioxanone) Suture Size 1 PDS PLUS Violet 27 Single Armed OS-4 Needle
PDS Plus Antibacterial (Polydioxanone) Suture Size 0 PDS Plus Violet 36 Single Armed CT-1 Needle
Gyrus ACMI Round Cutting Burrs - to be used with the Diego Elite system
Hematology Diluent M-30D used with BC-3200 and BC-3600 Hematology Analyzer; Part Numbers: (1) 105-005405-00 (2 x 5.5L container), (2) 105-005406-00 (20L container) The M-30D Diluent is an azide-free, filtered isotonic solution for counting and sizing blood cells. It is for use with the Mindray BC-3200 and BC-3600 Hematology Analyzer.
Hematology Diluent M-53D used with BC-5390 Hematology Analyzer; Part Number: 105-007867-00 (20L container) The M-53D diluent is an azide-free, filtered isotonic solution for counting and sizing blood cells. It is for use with the Mindray BC-5390 Hematology Analyzer.
Roast Beef Gravy Seasoning Manufacturer's code: PF07040000 packaged in a multi-walled paper bag with poly liner, 28 pounds
Spinal Jaxx Interbody Fusion Device, Model: 100001-511, Size: 9 H x 10 W x 25 L Product Usage: The Spinal Jaxx interbody fusion device is indicated for spinal fusion for patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The indicated patient population is skeletally mature patients who have had six (6) months of non-operative treatment. The Spinal Jaxx interbody fusion device must be used with autogenous bone graft material and with supplemental fixation.
Magstim Rapid Therapy System consisting of: Rapid Mainframe, Rapid Single Power Supply Unit , Rapid User Interface, Air Film Coil and Main Filters Product Usage For the treatment of major depressive disorders in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode.
Baker Jejunostomy Tubes: Product Code Equivalent Code (a) 655300160 655316 (b) 655500200 655520
Simplastic Suprapubic Puncture Instruments: Product Code Equivalent Code (a) 650704100 551310 (b) 650704120 551312 (c) 650704160 551316 Product Usage: RUSCH Simplastic Suprapubic Puncture Instruments are indicated for emergency suprapubic drainage of the bladder.
Rectal Catheters; Product Code Equivalent Code 580114 580114 Product Usage: Rectal Balloon Catheter is inserted into the rectum to measure the abdominal pressure as bladder filled.
VOLISTA StandOP Surgical Light; Model numbers VLT600 SF AIM STP, VLT600 DF AIM STP, Ref. codes ARD568811901, ARD568811911 ARD568811951, ARD568811961 The device is designed to illuminate the body of a patient during surgical operations, diagnostics and treatment. These surgical lights may be installed in surgical suites, examining rooms, doctors' surgeries and outpatient consultations.
Refractor Suspension Arm (P/N: 525004, 05 and 525006, 07) The Intended use of this medical device, as part of system to store and position ophthalmological examination and diagnostic equipment, is to store and position for examination a device commonly known as a refractor.
Conzerol (antipoxin) H2O2 Gel, Hydrogen Peroxide Gel 3%, 1.5 oz. tube, OTC, Manufactured for Elrose Labs, Inc., Sanford, FL
Conzerol zero molluscum contagiosum, Topical Cream, Net weight 0.78 (22g), Elrose Labs, Sanford Fl 32771 USA --- NDC 70223-001-06
Molleave, 2 oz bottle, OTC, Manufactured for Elrose Labs, Inc.
GFS Belgian Mini Chocolate Topped Eclairs, Keep Frozen, Net Wt . 700 g.; Signature Select Belgian Style Mini Eclairs, Keep Frozen, 420 g; Delizza Patisserie Belgian Custard Cream Mini Eclairs, 420 g.
Soap Korner Herbalist Red MD Kratom, Green Kali, powder, soapkorner.com
Diet Pepsi; NOW ASPARTAME FREE; 6 PACK; 16 OZ BOTTLES; 6-16 FLOZ BOTTLES (96 FL OZ)
Liberty Select Cycler (SW v.2.8.7), Material Number RTLR108343 Product Usage: The device is indicated for acute and chronic peritoneal dialysis.
Tramadol Hydrochloride 50 mg tablets, 120-count, Rx Only; Distributed by Quality Care Products, Temperance, MI 48182 Mfr. CSPC Ouyl Pharm Co., Ltd. Shijazhuang, Hebei, China; NDC 55700-0412-01
The Peru Chef Dry Potato, Product of Peru, Net Wt. 15oz/425gr, Imported and Distributed by MAS FOOD SERVICES Co.,
Doyen-Collin Mouth Gag 120MM/ General Instruments
Strauss Penis Clamp 130MM/General Instruments
Smoked Scallops, packaged and frozen in vacuum pouches, 4 oz & 16 oz packages. The 4 oz package has UPC 47094 20026
Signature Care Calcium Chews; Dietary Supplement; 500 mg Calcium; 25 mcg Vitamin D; Chocolate; 100 chews; Serving Size 1 chew;
4 oz 32-000452-0000 Product Usage: various first aid/emergency kits containing eyewash
Medline Remedy Essentials No Rinse Foaming Cleanser: No Rinse Foam; CHG Compatible, pH balanced, Fragrance Free - for all ages 4oz (MSC092FBC04): 24 bottles/case; 8oz bottles (MSC092FBC08): 12 bottles/case; Ingredient: Water, TEA-Lauryl Sulfate, Aloe Barbadenis, Propylene Glycol, Sodium Lauryl Lacitylate, Iodopropronyl, Butylcarbamate, DMDM Hydanton Triethanolamine, Citric Acid. Manufactured for Medline Industries, Inc. Northfield, IL www.Medline.com
Original Smoked Oysters, packaged in vacuum pouches, net wt. 2.25 oz. or 16 oz.. UPC 47094 20002
Zhong Hua Jiu (menthol 1%) Patch, Distributed by United Pacific Company, UPC 6 924938 100226, NDC 53614-001-02
Decitabine for Injection, 50mg per vial, Rx only, Manufactured by: Cipla Ltd., Verna Goa, India, Manufactured for: Cipla USA, Inc., 1560 Sawgrass Corporate Parkway, Suite 130, Sunrise, FL 33323, NDC 69097-285-37
Bruschetta Mix packaged under the following brands and sizes: 1. Tastebuds, Net Wt. 12 oz. (340g), UPC 38232-37403. Shipping case: H. Brooks, 37403, Net wt. 12 oz. (340g), K*319, Keep Refrigerated, 6 units per case, Distributed by H. Brooks & Co Mpls. MN 55112. 2. Quick & Easy Fresh Cut, Net Wt. 12 oz. (340g) UPC 38232-37403, shipping case: Supervalu, 38591, 6/12 oz., Net Wt 5.30 lbs., SV*069, Keep Refrigerated, 6 units per case Distributed by Supervalu, Eden Prairie, MN 55344. 3. H. Brooks, 38914, Bruschetta 5#, K*195, Keep Refrigerated, 1 unit per case, Distributed by H. Brooks & Co Mpls, MN 55112. 4. Reinhart, 82826, Brushetta Mix, 5#, Manufactured by Cut Fruit Express Mpls. MN 55076 5. Upper Lakes Foods, 143900, Bruschetta Mix, 5#, UPC 00001-43900, Manufactured by Cut Fruit Express Mpls. MN 55076.

Product Quantity
Delizza: 9664 cases; GFS: 3819 cases; Signature Select: 5400 cases
Natural Selections = 2422 pkgs; ZooLogics = 2226 pkgs.
3300 Cases (3 bags per case) - total of 9900 bags
219/2.25 oz vacuum pouches and 28/16 oz vacuum pouches

Reason for Recall
After two and a half years, the battery fuel gauge may indicate a higher battery charge than what is available.
The NBP measurement of Intellivue X3 Patient Monitor shows intermittently only mean values instead of the diastolic and systolic blood pressure values. This is caused by a falsely detected NBP cuff, which is leading to wrong internal NBP setting. Furthermore, occasionally the Monitor shows the Check Touch Input message and the monitor is inoperable with the touch interface.
A programing error in some Model FD100 HomeSafe AutoAlert Pendants will render the fall detection feature inoperable.
The infusion sets were manufactured with an incorrect spin collar.
Following the completion of sterilization cycle(s) of the impacted Hex Driver, the epoxy color band on the impacted Hex Driver can migrate down the shaft and/or potentially onto the sterilization tray or caddy.
iQ200 Series Urine Microscopy Analyzer may intermittently fail to read urine sample dilution barcode labels causing erroneous results that could delay treatment for health conditions such as hematuria.
Blood products, which did not meet the acceptable product specifications for release, were distributed.
The device may process the same sample with two different sample IDs and sample information while using the single tube loader, which has the potential for erroneous results due to the mis-identification.
Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Blood products, which were not quarantined after receiving information regarding a post donation illness, were distributed.
The firm recalled cheese after a sample tested positive for Listeria monocytogenes by the State of New York.
Product may contain a gap between the handle and metal chisel which can lead to failure to properly disinfect or sterilize between use.
Orthofix is conducting a voluntary recall of the Connector System Large Set Screw (PN: 79-2002) with affected Lot Numbers 001 and 002, and Small Set Screw (PN: 79-2003) with affected Lot Numbers 002, 003 and 004. Through the company's manufacturing controls, size discrepancies were noted with the drive feature for both the large and small sets screws. As a result, it is possible that (1) the set screw drive feature will not accept the Set Screw Driver (PN: 79-1006) or (2) the driver may get wedged in the corners of the drive feature (false bottom) which may lead to a stripped set screw.
BMD has identified that the product code/lot number combination identified above may have ineffectively fused tubing and ENFit(TM) connector.
VITROS TSH reagent lots have been found to generate higher than expected Calibrator level 2 signals on some customer systems. These Calibrator Level 2 responses cause a higher than expected frequency of customer generated calibration curves to fall outside of the calibration quality parameter measuring the gradient of the Customer Calibration Curve between Calibrator Level 2 and Calibrator Level 3.
Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.
One lot of D-RAD Self-Taping Locking Screws used with the Distal Radius Fracture Kit were machined out of specification. Screws measured over tolerance within the head thread form by 0.002-0.003 inch.
A component used within the braking system may break resulting in one or more brake pedals on the bed staying in brake or not being engaged which could result in unwanted bed movement and possible patient or user injury.
Possible blood leaks through the hydrophobic portion of the Pall LG6NS LeukoGuard Leukocyte Reduction Arterial Blood Filters.
During continuous postmarket surveillance activities, we have noticed a potential malfunction of individual foot controls of the type S-N1/S-N2. In case the error occurs, the foot control might not switch back to zero position when the pedal is released. Consequently, the motor keeps rotating. If this happens during automatic thread cutting or automatic screwing-in of implants, it may, in the worst case, lead to a serious injury of the patient.
All American Seasonings is recalling Lost Cajun Gumbo Base because an ingredient was contaminated with Salmonella.
Three (3) lots were distributed with the incorrect expiry date on the label. The lots were labeled with an expiry date of five (5) years from date of manufacture instead of the correct expiry date of two (2) years from date of manufacture.
There is possibly a difference between the measured dioptric value of the subjective measurement mode and the objective measurement mode on ARK-1s.
Certain lots of M-30D diluent used with BC-3200 and BC-3600 Hematology Analyzers and M-53D diluent used with BC-5390 Hematology Analyzers may cause the system to produce an elevated platelet background count.
Certain lots of M-30D diluent used with BC-3200 and BC-3600 Hematology Analyzers and M-53D diluent used with BC-5390 Hematology Analyzer may cause the system to produce an elevated platelet background count.
The implant size is incorrectly etched on the implant. The size listed on the box is correct.
Beckman Coulter has determined that there is a potential for under-reporting casts. This can occur if per high-power field (/HPF) units of measurement for casts are selected in the iQ200 software, but the abnormal threshold and/or grading format is set up based on reporting per low-power field (/LPF)* or *per microliter. This may occur during initial method validation or if settings are altered after the initial validation.
Users manuals not supplied with 4800-00T US Rapid Therapy System
These products contain latex, but the following statement is not included on any level of product packaging: Caution: This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions.
The manufacturer received complaints indicating that the device's central handle holder detaches easily from the handle holder ring on the light head during clinical use. In the event of such detachment, particles from the handle holder ring could fall into the sterile field during a procedure.
Product has been found with a missing Washer, Retaining Ring, and/or Stop Screw. Recalling firm was notified by distributor that Refractor Suspension Arm fell on a patient s lower torso along with the arm housing
Products may be contaminated with Listeria monocytogenes
S.K. Herbalist Red MD Kratom powder may be contaminated with Salmonella.
Natural Selections Duck with Organic Vegetables Meals for Dogs are recalled due to potential to be contaminated with Salmonella.
Natural Selections Chicken Meals for Dogs and ZooLogics Chicken with Organic Vegetables Meals for Dogs are recalled due to potential to be contaminated with Salmonella.
ZooLogics Turkey with Vegetables Meals for Dogs are recalled due to potential to be contaminated with Salmonella and E. coli O128.
The recalling firm identified a software issue related to the Patient Line Check (PLC) which may result in an increased risk of Overfill (also known as Increased Intraperitoneal Volume, IIPV). Overfill/IIPV may result in serious injury or death.
Labeling: Incorrect or Missing Lot and/or Exp Date
Florida Department of Agriculture and Consumer Services collected and tested from a retailer in Miami a sample of The Peru Chef Dried Potatoes collected from a retailer in Miami. The sample tested 20.8 mg/serving of undeclared sulfites.
The plastic sleeves of the Penis Clamp and Mouth Gag may stick together during or after reprocessing rendering the instruments unusable.
Smoked Scallops, packaged and frozen in vacuum pouches, are recalled because product did not meet minimum Water Phase Salt (WPS) percentage of 3.5%.
A packaging revision and lack of revision to the corresponding packaging batch record caused the labeling for the firm's Signature Care brand Calcium Chews dietary supplement to declare a higher level of Vitamin D than the product actually contained. The bag declares 25 mcg (1000 IU) of Vitamin D. The product actually contains 12.5 mcg (500 IU) of Vitamin D.
Firm is recalling first aid/emergency kits and cabinets which contain Honeywell Eyewash (3 lots) which is being recalled due to leaking bottles.
Product has the potential to be contaminated with Burkholderia cepacia
Original Smoked Oysters, packaged in vacuum pouches, are recalled because the product is not intended to be packaged in a vacuum pouch. This product is cold smoked and low salt and will not meet the minimum standard of Water Phase Salt % for vacuum pouch processing or consumption. Consumption of this product without maintaining the temperature below 38 degrees F may lead to the introduction of Clostridium botulinum toxin.
CGMP Deviations: the product was produced with substandard GMP manufacturing processes.
Failed impurities/degradation specifications: Failure to water content and impurity
Bruschetta Dip and Bruschetta Mix are recalled because they contain undeclared Milk & Soy.
Amaranth Flour is recalled due to potential for contamination with Salmonella.

Code Info
Model 867030 - All devices shipped from June 2017
Model FD100 HomeSafe AutoAlert Pendants with Reference Number 300000219841 and 300000219851 All materials with R and UR prefixes remanufactured between 07-28 -2017 and 1 1-06-20 17; 100% of this material (UDI) are affected.
All iQ200 Series in the field with barcode reader model NFT-2100
Code: 101 The consumer alert affects all packages with this code.
Models: 26.08.506 OSTEO 8MM AND W/HDL 20CM/8IN 26.08.507 OSTEO 10MM AND W/HDL 20CM/8IN 26.08.508 OSTEO 12MM AND W/HDL 20CM/8IN 26.08.509 OSTEO 13MM CRVD R 10 23CM/9IN 26.08.619 OSTEO 19MM CRVD R 10 23CM/9IN (No US distribution) 26.08.712 OSTEO 12MM CRVD R 6 23CM/9IN (No US distribution) 26.08.715 OSTEO 15MM CRVD R 6 23CM/9IN (No US distribution) 26.08.718 CHARC OSTE 18MM CRD R6 23CM/9 26.08.812 OSTEO 12MM CRVD R 8 23CM/9IN (No US distribution) 26.08.815 OSTEO 15MM CRVD R 8 23CM/9IN (No US distribution) 26.08.818 CHARC OSTE 18MM CRD R8 23CM/9 (No US distribution) 26.08.900 ARTHROPIC ARTH 18CM 45TUFF HDL 26.08.910 RUTREK CHIS 20CM/8 DBL CUT BLD
Lot Numbers: NGBN2862, NGAXX217, NGAVX225
Lot Numbers: NGAXX216, NGAVX224, NGBN2861
Lot Numbers: NGAY4533, NGAX3534, NGARX206
Lot 5470, expiry date: 24-May-2018 Lot 5430, expiry date: 01-Mar-2018 (not distributed in the US.) Lot 5178 was also affected by this issue, expired on 31-Mar-2017,
S159AW9192 through S305AW2321 Beds manufactured from June 8, 2017 to November 1, 2017
Lot 80681, Manufacture Date: February 22, 2018
Product code: PDPB346 GTIN: 10705031048829 Product lot: LMM273
Product code: PDP695H GTIN: 10705031048584 Product lot: LL6590
Product code: PDP346H GTIN: 10705031048126 Product lot: LL6459
GFS Product UPC 093901859372, Lot code: L1D1018, Best Before 09/06/19; Signature Select UPC 021130085460, Lot code: L1G1018, Best Before 09/07/19; Delizza UPC 676670001069; Lot code: L1M1018, Best Before 09/09/19
Production Code: ttttPS031481 where 'tttt' stands for the 4-digit time code starting with time code 0647 and ending approximately 0730. The first package code would then be 0647PS031481 and a best taste date code on all packages of JUN 18 18. UPC on incorrect/old RSW secondary package - 012000100413 Best taste date code on all packages of JUN 18 18.
Natural Selections brand: Lot #43887, manufacture date 1/30/2018. ZooLogics brand: Lot #44037, manufacture date 2/7/2018.
Item number MSC092FBC04; lots M06691, M07247 ; Item number MSC092FBC08; lots M05703 and M06691