BEUDAMED
    FDA Recall Open, Classified

    Ultracell Wick with 80cc Collection Bag, 20/box

    Recall: Z-1199-2023 · Initiated December 20, 2022

    Recall

    Recall Number
    Z-1199-2023
    Event Number
    91488
    Firm
    Beaver Visitec International, Inc.
    FEI Number
    1211998
    Product Code
    HOZ
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    December 20, 2022
    Posted
    March 1, 2023
    Address
    500 Totten Pond Rd, 10, City Point Waltham, MA, 02451-1916

    Description

    Ultracell Wick with 80cc Collection Bag, 20/box

    Reason

    Device packaging may contain open seals, compromising product sterility.

    Action

    A consignee letter was issued to impacted customers on January 18, 2023. The communication advises consignees to immediately examine inventory and quarantine product from impacted lots. If further distribution has occurred, a sub-recall should be initiated. A completed copy of the Business Response Form shall be completed and returned to [email protected].

    Distribution

    US distribution in AL, CA, CO, DC, FL, GA, IL, LA, MD, MN, MT, NC, NH, NJ, NM, NY, OH OK, PA, RI, TN, TX, UT, VA, VT, WA, and WI OUS distribution to Canada, Japan, and South Africa

    Quantity

    4640 units in total