BEUDAMED
    FDA Recall Open, Classified

    SYRINGE,BULB,2OZ/60CC,GREEN, Part: 300055070, packaged inside Alcon Custom-Pak Surgical Procedure Packs, Products: 18018-06, 3865-44, 5675-76, 13554-11, 18018-06, 15190-16 , 15190-16, 15190-16, 15190-16, 15190-16, 13554-11, 5918-39, 15190-16, 15190-16, 9208-66, 9208-66, 5675-76, 5918-39, 9208-66, 15190-16, 9065-25, 5918-39, 16066-15, 16066-15

    Recall: Z-1370-2024 · Initiated February 21, 2024

    Recall

    Recall Number
    Z-1370-2024
    Event Number
    94094
    Firm
    Alcon Research, LLC
    FEI Number
    1000117501
    Product Code
    LRO
    Status
    Open, Classified
    Root Cause
    Nonconforming Material/Component
    Initiated
    February 21, 2024
    Posted
    March 22, 2024
    Address
    9965 Buffalo, Speedway Houston, TX, 77054-1309

    Description

    SYRINGE,BULB,2OZ/60CC,GREEN, Part: 300055070, packaged inside Alcon Custom-Pak Surgical Procedure Packs, Products: 18018-06, 3865-44, 5675-76, 13554-11, 18018-06, 15190-16 , 15190-16, 15190-16, 15190-16, 15190-16, 13554-11, 5918-39, 15190-16, 15190-16, 9208-66, 9208-66, 5675-76, 5918-39, 9208-66, 15190-16, 9065-25, 5918-39, 16066-15, 16066-15

    Reason

    Medline Bulb irrigation syringes recalled due to potential for packaging sterile barrier to be breached, and these syringes were packed inside surgical procedure packs that were subsequently terminally sterilized, so after the packs are opened, syringes should be discarded at surgical case end, and not reshelved, because the use of non-sterile bulb irrigation syringes may increase infection risk.

    Action

    On 2/21/24, correction notices were mailed to customers who were asked to do the following: 1) Review your inventory to determine if you have any affected product within your facility. 2) If you have any affected Custom Pak lots in inventory, please use the included stickers to label any affected product. If you have previously reshelved either of the affected Medline Bulb Irrigation Syringe lots, dispose them. 3) All components inside the Pak are intended to be used only for one specific surgical case and should be discarded at the end of the surgical case. 4) Forward the correction notice to all departments within your organization who may be in possession of affected product; and any other organization to which this product may have been transferred. 5) Complete and return the response form via email to [email protected] Customers with questions or concerns can call the firm at 1-800-862-5266.

    Distribution

    US Nationwide distribution in the states of OH, WV.

    Quantity

    886