Device product
Centurion hook kits labeled as: a) STERILE SKIN HOOK FINE (EA3975F), Product Code 66660; b) STERILE SMALL 2 PRONG SKIN HOOK (25754), Product Code 67105; c) STERILE NEWS TRACH HOOK(83300), Product Code 67810; d) STERILE LILLIE EAR HOOK DELICATE 7", Product Code I68655
Z-1435-2024
Product summary
- Event
- Event 94136
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1520 units
- Official record key
device-enforcement:Z-1435-2024
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) 66660, UDI/DI 60653160052154 (case) 00653160052152 (each), Lot Numbers: 2023042790, 2023091190; b) 67105, UDI/DI 60653160061880 (case) 00653160061888 (each), Lot Numbers: 2023042690; c) 67810, UDI/DI 30653160196703 (case) 00653160196702 (each), Lot Numbers: 2023060790, 2023070790; d) I68655, UDI/DI 00653160317220 (case) 10653160317227 (each), Lot Numbers: 2023061290
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