BEUDAMED
    FDA Recall Open, Classified

    Brand Name: B. BRAUN MEDICAL INC. Product Name: CESK SHANDS JACKSONVILLE 20055717 Model/Catalog Number: 555884 Software Version: N/A Product Description: CESK SHANDS JACKSONVILLE 20055717 Component: No

    Recall: Z-2269-2026 · Initiated January 29, 2026

    Recall

    Recall Number
    Z-2269-2026
    Event Number
    98862
    Firm
    B Braun Medical Inc
    FEI Number
    2521402
    Product Code
    OGE
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    January 29, 2026
    Posted
    May 29, 2026
    Address
    824 12th Ave, Bethlehem, PA, 18018-3524

    Description

    Brand Name: B. BRAUN MEDICAL INC. Product Name: CESK SHANDS JACKSONVILLE 20055717 Model/Catalog Number: 555884 Software Version: N/A Product Description: CESK SHANDS JACKSONVILLE 20055717 Component: No

    Reason

    B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL Liquid Adhesive, that they have issued a voluntary recall due to potential cracking of the butyrate tubing (outside tube), which renders the product unusable.

    Action

    On January 29, 2026 and May 6, 2026 URGENT MEDICAL DEVICE RECALL letters were sent to customers to notify them of a recall of a kit component. Actions to be taken include to review inventory to identify affected product, discontinue use and segregate. Using the acknowledgement form, respond to B Braun who will send further instructions to return the product. Should there be any questions, comments, or concerns regarding the product you have received, please feel free to contact (844-903-6417) or [email protected];

    Distribution

    US Nationwide distribution in the states of AL, FL, PA, TX, VA, WA.

    Quantity

    680