BEUDAMED
    FDA Recall Open, Classified

    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

    Recall: Z-1293-2025 · Initiated February 10, 2025

    Recall

    Recall Number
    Z-1293-2025
    Event Number
    96285
    Firm
    Alcon Research LLC
    FEI Number
    1610287
    Product Code
    LRO
    Status
    Open, Classified
    Root Cause
    Software design
    Initiated
    February 10, 2025
    Posted
    March 6, 2025
    Address
    6201 South Fwy Fort, Worth, TX, 76134-2099

    Description

    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

    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.

    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

    Distribution

    US Nationwide distribution in the states of AK, AR, AZ, FL, MD, MN, NC, NE, OH, PA, TX, WA, WI.

    Quantity

    2511