Device product
eye-pak 7407 Tray Support Cover REF 8065740745
Z-2694-2014
Product summary
- Event
- Event 68487
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2462
- Official record key
device-enforcement:Z-2694-2014
Official wording
Reason: The peel pouches of the Tray Support Covers may be insufficiently sealed so that sterility cannot be assured.
Code information: Item Number 8065740745 with Lot numbers 613207-07V, 613221-07V, 613228-07V, 613249-07V, 613256-07V, 35206V, and 352699V.
Distribution pattern: Worldwide Distribution - Nationwide Distribution and the countries of Australia, Belgium, and Canada.
Derived failure modes
-
Sterility assurance
sterility cannot be assured