BEUDAMED
    FDA Enforcement Class II Ongoing

    BAUSCH + LOMB CATARACT PACK, REF VAL001CPMEA. Convenience kit used in surgical procedures.

    Recall: Z-0161-2023 · Reported November 9, 2022

    Enforcement

    Recall Number
    Z-0161-2023
    Event ID
    90946
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    MEDLINE INDUSTRIES, LP - Northfield
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    N/A
    Report Date
    November 9, 2022
    Initiation Date
    September 30, 2022
    Classification Date
    November 1, 2022
    Address
    3 Lakes Dr, N/A, Northfield, IL, 60093-2753, United States

    Description

    BAUSCH + LOMB CATARACT PACK, REF VAL001CPMEA. Convenience kit used in surgical procedures.

    Reason

    Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.

    Code Info

    GTIN (01) 10195327108168, Lot Number 22DBL466

    Distribution

    US Nationwide distribution in the states of CA, MN, NC, NY, OK, PA, TN, TX.

    Quantity

    708 kits