Device product
Custom Pak 9319-27. Single-use medical devices and accessories designed by medical professionals for a specific ophthalmic surgical procedure.
Z-0195-2016
Product summary
- Event
- Event 72363
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5 units
- Official record key
device-enforcement:Z-0195-2016
Official wording
Reason: The recalled lot of custom paks are labeled as latex free and contain latex gloves rather than the specified non-latex gloves.
Code information: 1792733H, 1783925H, 1785227H, 1786729H
Distribution pattern: Distributed in VT.
Derived failure modes
-
Unknown
The recalled lot of custom paks are labeled as latex free and contain latex gloves rather than the specified non-latex gloves.