Device product
B. Braun CARESITE Port Access Kit w/Tegaderm, REF 375214, Central Venous (cardiac) Catheter Tray (REF number corrected 11/23/2022)
Z-0265-2023
Product summary
- Event
- Event 91017
- Status
- Terminated
- Classification
- Class II
- Quantity
- 240 cases of 20 units
- Official record key
device-enforcement:Z-0265-2023
Official wording
Reason: The kits were incorrectly labeled with an extended expiration date of 02/21/2024 instead of 02/10/2024.
Code information: UDI/DI 10809160283875, Batch/Lot number 298442
Distribution pattern: US Nationwide distribution in the state of Pennsylvania.
Derived failure modes
-
Labeling or packaging
incorrectly labeled