BEUDAMED
    FDA Enforcement Class II Ongoing

    Brand Name: B. BRAUN MEDICAL INC. Product Name: SESK UPMC DOUBLE CATHETER TRAY Model/Catalog Number: 530134 Software Version: N/A Product Description: SESK UPMC DOUBLE CATHETER TRAY Component: No

    Recall: Z-2270-2026 · Reported June 10, 2026

    Enforcement

    Recall Number
    Z-2270-2026
    Event ID
    98862
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    B Braun Medical Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 10, 2026
    Initiation Date
    January 29, 2026
    Classification Date
    May 29, 2026
    Address
    824 12th Ave, Bethlehem, PA, 18018-3524, United States

    Description

    Brand Name: B. BRAUN MEDICAL INC. Product Name: SESK UPMC DOUBLE CATHETER TRAY Model/Catalog Number: 530134 Software Version: N/A Product Description: SESK UPMC DOUBLE CATHETER TRAY 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.

    Code Info

    Lot Code: Model No 530134, UDI-DI (Primary Device) 04046964305856, UDI-DI (Unit Device ID) 04046964305849, Lot Number 0062019148

    Distribution

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

    Quantity

    390