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
FDA Recall Z-1293-2025 · Posted 2025-03-06
Advertisement
Recalling FirmAlcon Research LLC
Recall StatusOpen, Classified
Product CodeLRO
Date Initiated2025-02-10
Product Quantity2511
Reason for Recall
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.
Firm 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
Root Cause
Software design
Distribution Pattern
US Nationwide distribution in the states of AK, AR, AZ, FL, MD, MN, NC, NE, OH, PA, TX, WA, WI.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement