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TRI TS BASEPLATE SIZE 3. Part Number: 5521-B-300.
Stryker has identified that Triathlon Universal Baseplate Size 3 (lot UZD9IB), is contained in packaging labeled as Triathlon Universal Baseplate Size 4 (lot TYX7OB), and Triathlon Universal Baseplate Size 4 (lot TYX7OB), is contained in packaging labeled as Triathlon Universal Baseplate Size 3, (lot UZD9IB).
Medline convenience kits: CMH CENTRAL LINE DRESSING CHANGE KIT EBSI1705A ...
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
MEDLINE Medical Procedure Kits labeled as: LAPAROSCOPY COMBINED - NO NDL, Medli...
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.
Description/REF: EPIDURAL CATHETER KIT: 19 GA X 90 CM/ASK-05502-VM1; EPIDURAL ...
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
MEDLINE Medical Procedure Kits labeled as: NURSING KIT, Medline Kit Number/SKU ...
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.
Medline EBSI Kit EBSI1534
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Description/REF: RA CATH KIT: 20 GA X 1 3/4 IN/TJ-04020-1; RA CATH KIT: 20 GA ...
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
MEDLINE Medical Procedure Kits labeled as BIOBURDEN TEST KIT, Kit Uro Robot Cyst...
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.
Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, 004...
Exposure to the low purge pressure occurrence may result in persistent low purge pressure alarms and, in some cases, interruption or loss of mechanical circulatory support.
Description/REF: DRAINAGE KIT/AK-01600, DRAINAGE KIT/AK-01601, DRAINAGE KIT/ASK-...
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
Aripiprazole Tablets USP, Rx only, 30 mg, 30 tablets, Marketed by: Ajanta Pharma...
Product Mix-Up: A bottle containing Voriconazole Tablets 50 mg was labelled and distributed as Aripiprazole Tablets USP 30 mg.
Description/REF: PI JACC KIT: 2L 5.5 FR X 15 CM CG+/ASK-41552-LTAC; PI JACC KIT:...
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
MEDLINE Urethral Catheterization Tray, Red Rubber Latex, Medline Product Number/...
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.
MEDLINE Medical Procedure Kits labeled as CLOVIS HYSTEROSCOPY, CSC-N PELVISCOPY,...
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.
iLet Bionic Pancreas, REF: BB1001
The reason for the recall is: it was found in version 3.3.6 of the iLet ACE Pump firmware and all previous releases that a screen unlock failure could occur when the user successfully slides the unlock slider on the Lock Screen, no screen transition occurs, and the user remains on the Lock Screen. Because the user cannot exit the Lock Screen, the user is unable to perform a cartridge change or meal announcement. If this occurs and therapy is in progress, therapy will continue normally until the insulin cartridge is depleted. The user will be unable to perform a cartridge change or a meal announcement and will be stuck on the screen until the battery fully drains. This can lead to hyperglycemia.
Product Name: STAAR ICL Calculation Software Software Version: Version 8.00 Pr...
Due to a software coding issues for calculating the implant orientation diagram printout for the implantation for toric implantable collamer lenses.
Description/REF: AGBA PICC G4 Stylet: 3L 6FR x 55CM BP/DLX-45563-VPSB; AGBA PI...
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
Description/REF: CVC KIT: 16 GA X 8IN/AK-04210, CVC KIT: 1-L 16 GA X 8IN (20 CM)...
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
MEDLINE Medical Procedure Kits labeled as: 1) BASIC HEART PACK, Medline Kit/S...
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.
TRI TS BASEPLATE SIZE 4. Part Number: 5521-B-400.
Stryker has identified that Triathlon Universal Baseplate Size 3 (lot UZD9IB), is contained in packaging labeled as Triathlon Universal Baseplate Size 4 (lot TYX7OB), and Triathlon Universal Baseplate Size 4 (lot TYX7OB), is contained in packaging labeled as Triathlon Universal Baseplate Size 3, (lot UZD9IB).
Med Pride, Triple Antibiotic Ointment, Bacitracin Zinc 400 units, Neomycin Sulfa...
CGMP Deviations; deficiencies observed during FDA inspection
MEDLINE Medical Procedure Kits labeled as: CATH 22F ROBINSON STRL 5'S PK, Medli...
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.
ConMed AirSeal 12 mm Access Port and Obturator with Blunt Tip, 120mm Length. Cat...
Potential for overpressure alerts.
ALYON Surgical Lighting System
The the plus and minus buttons (+/-) used to control light intensity on the light heads may detach.