Recall Z-0195-2016 ยท LRO General Surgery Tray
Alcon Research, Ltd.
Custom Pak 9319-27. Single-use medical devices and accessories designed by medical professionals for a specific ophthalmic surgical procedure.
| Date | Oct 30, 2015 (initiated Sep 21, 2015) |
| Status | Terminated |
| Reason | The recalled lot of custom paks are labeled as latex free and contain latex gloves rather than the specified non-latex gloves. |
| Root cause | Mixed-up of materials/components |
| Action | The recalling firm notified the consignee on 9/21/15 via phone call, and with a follow up visit to the consignee site. The recalled units were recovered. |
| Quantity | 5 units |
| Distribution | Distributed in VT. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K880961 | ALCON SURGICAL PROCEDURE PACKS Alcon Laboratories, Apr 29, 1988 |