Device product
Alcon Custom Pak
Z-0053-2018
Product summary
- Event
- Event 77965
- Status
- Terminated
- Classification
- Class II
- Quantity
- 33 units
- Official record key
device-enforcement:Z-0053-2018
Official wording
Reason: Alcon is initiating a medical device recall, after receiving notification from a supplier of a recall for x-ray detectable sponges. The one product referenced in the supplier recall notification, is used within Alcon Custom Paks.
Code information: 2033459H, 2034186H, 2034491H
Distribution pattern: States in the US - WI, NY, MO
Derived failure modes
-
Unknown
Alcon is initiating a medical device recall, after receiving notification from a supplier of a recall for x-ray detectable sponges. The one product referenced in the supplier recall notification, is used within Alcon Custom Paks.