Device product
Jackson-Pratt Channel Drain Silicone Round, Fully Fluted w/10FR Trocar. Sterile. Rx Distributed by Cardinal Health, USA Catalog Number: JP-2187 For wound drainage.
Z-1233-2017
Product summary
- Event
- Event 76368
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3040 units
- Official record key
device-enforcement:Z-1233-2017
Official wording
Reason: Product sterility compromised due to breach of sterile barrier
Code information: Lot Number: P1546816 Expiration date: January 2021
Distribution pattern: To PR only
Derived failure modes
-
Sterility assurance
sterility compromised