Device product
Centurion manual surgical kits labeled as: a) SUTURE REMOVAL TRAY, Product Code TRI55405; b) SUTURE REMOVAL SET, Product Code 60265 MEDLINE manual surgical kits labeled as: a) SUTURE REMOVAL TRAY, Product Code 60280; b) SUTURE REMOVAL TRAY, Product Code 86125; c) SUTURE REMOVAL KIT, Product Code SR60555; d) SKIN STAPLE REMOVER, Product Code TRI44105
Z-1445-2024
Product summary
- Event
- Event 94136
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 23,290 units
- Official record key
device-enforcement:Z-1445-2024
Official wording
Reason: Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
Code information: a) TRI55405, UDI/DI 20193489112709 (case) 10193489112702 (each), Lot Numbers: 2023022390 b) 60265, UDI/DI 50653160090982 (case) 00653160090987 (each), Lot Numbers: 2023041190 MEDLINE: a) 60280, UDI/DI 20193489111948 I(case) 10193489111941 (each), Lot Numbers: 2023031790, 2023070590, 2023112790; b) 86125, UDI/DI 20193489111832 (case) 10193489111835 (each), Lot Numbers: 2023032090, 2023120490; c) SR60555, UDI/DI 20193489111955 (case) 10193489111958 (each), Lot Numbers: 2023111590; d) TRI44105, UDI/DI 20193489112730 (case) 10193489112733 (each), Lot Numbers: 2023072490
Distribution pattern: Worldwide distribution - US Nationwide and the countries of Panama, Canada.
Derived failure modes
-
Labeling or packaging
weak seal
-
Sterility assurance
breach of sterility