Device product
Scalpel and StatLock included with HydroPICC Catheter Kit - PICC-142, Peripherally Inserted Central Catheter
Z-0199-2023
Product summary
- Event
- Event 90981
- Status
- Terminated
- Classification
- Class II
- Quantity
- 79 kits
- Official record key
device-enforcement:Z-0199-2023
Official wording
Reason: Scalpel and StatLock components packaged with specific lots of the HydroPICC catheter have a shorter expiration date than what is listed on the outer kit package.
Code information: UDI-DI: 00862559000418 Catheter Kit Lots/Expiration Dates 09112001 Exp 9/24/2021 10212001 Exp 10/21/21 10282001 Exp 11/18/21 Scalpel Lots/Expiration Dates R18-08-010 Exp Feb-21 R19-01-009 Exp Jun-21 R20-01-010 Exp Aug-22 StatLock Lots/Expiration Dates R18-09-008 Exp 5/28/2021
Distribution pattern: Domestic distribution to NC, RI, NJ, and IL. No foreign distribution.
Derived failure modes
-
Unknown
Scalpel and StatLock components packaged with specific lots of the HydroPICC catheter have a shorter expiration date than what is listed on the outer kit package.