Recall Z-0354-2023 ยท LRO General Surgery Tray
Alcon Research, LLC
Alcon Custom Pak Surgical Procedure Pack
| Date | Dec 1, 2022 (initiated Oct 31, 2022) |
| Status | Open, Classified |
| Reason | Due to difficulty removing the liner on the adhesive components of the affected drapes and as a result may render the product unusable. In addition, the manufacturer of the drapes has observed an increase in reported adhesive related skin injuries for these affected lots. |
| Root cause | Nonconforming Material/Component |
| Action | On 10/31/2022, the firm sent an "URGENT: VOLUNTARY MEDICAL DEVICE FIELD CORRECTION" Letter via overnight mail informing customers about the problem, the product and the actions to be taken. Customers are instructed to: 1. See table 1 for list of affected Alcon Custom Pak lots (included in list) that were distributed to their facility. They may receive Custom Pak lots assembled prior to this Field Correction notification, and as a result, may be receiving affected inventory in future shipments. If they receive any affected lots in the future, they will be identified by a sticker. The stickers |
| Quantity | 308,610 kits |
| Distribution | Worldwide Distribution: U.S.(nationwide) to states of: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY; and O.U.S. (foreign) to countries of: Austral |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K880961 | ALCON SURGICAL PROCEDURE PACKS Alcon Laboratories, Apr 29, 1988 |