Recall Z-1293-2025 ยท LRO General Surgery Tray
Alcon Research LLC
Alcon Custom Pak with Non-Latex Symbol, Pak: 12771-18, 18050-10, 18252-17, 12698-09, 15632-10, 3141-45, 12630-07, 18925-05, 19265-05, 13894-16, 17550-08, 12236-18, 11854-15, 8043-29, 12466-17, 15599-17, 14764-09, 13194-16, 17069-09
| Date | Mar 6, 2025 (initiated Feb 10, 2025) |
| Status | Open, Classified |
| Reason | Customer-designed sterile surgical procedure packs contain latex components as specified; but, the content label sealed within the transparent sterile pouch contains the symbol for a latex-free product. If users or patients with latex sensitivity come into contact with latex, an allergic reaction may occur. |
| Root cause | Software design |
| Action | On 2/10/2025, correction notices were mailed to customers who were asked to do the following: 1) Do not open packaging. Using the provided stickers, adhere one sticker to the outside of affected product near the label to identify it as containing latex. 2) Complete and return the response form electronically via: https://qrco.de/non-latex-symbol Should you have any questions or concerns about this matter, please feel free to call the firm at A 1-800-862-5266 |
| Quantity | 2511 |
| Distribution | US Nationwide distribution in the states of AK, AR, AZ, FL, MD, MN, NC, NE, OH, PA, TX, WA, WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K880961 | ALCON SURGICAL PROCEDURE PACKS Alcon Laboratories, Apr 29, 1988 |