Device product
Covidien EndoStitch" Polysorb Single Use Loading Unit; Product numbers: 170053 and 170071;
Z-2281-2026
Product summary
- Firm
- Covidien, LP
- Event
- Event 98871
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2448 units
- Official record key
device-enforcement:Z-2281-2026
Official wording
Reason: The presence of holes in the pouch may compromise the package s ability to maintain the sterile barrier and protect the product from environmental exposure.
Code information: 1. Product Number: 170053; UDI-DI: 10884521126732; UPN: 20884521126739; Lot number: J5L2332Y; 2. Product Number: 170071; UDI-DI: 10884521126787; UPN: 20884521126784; Lot number: J5H2924Y;
Distribution pattern: Domestic: Nationwide distribution; International: Austria, Canada, Denmark, France, Italy;
Derived failure modes
-
Unknown
The presence of holes in the pouch may compromise the package s ability to maintain the sterile barrier and protect the product from environmental exposure.