Recall Z-0053-2018 ยท LRO General Surgery Tray
Alcon Research, LTD.
Alcon Custom Pak
| Date | Aug 25, 2017 (initiated Aug 8, 2017) |
| Status | Terminated |
| 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. |
| Root cause | Nonconforming Material/Component |
| Action | The medical user was sent a customer recall notification letter on 8/7/17. The medical user is requested to return the unused, affected Custom Paks to Alcon. Upon receipt and verification, Alcon will destroy the affected sponges in a controlled manner via physical destruction. |
| Quantity | 33 units |
| Distribution | States in the US - WI, NY, MO |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K880961 | ALCON SURGICAL PROCEDURE PACKS Alcon Laboratories, Apr 29, 1988 |