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Recall Observatory FDA recall evidence

Device product

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

Z-2270-2026

January 29, 2026

Class II

Product summary

Firm
B Braun Medical Inc
Event
Event 98862
Status
Ongoing
Classification
Class II
Quantity
390
Official record key
device-enforcement:Z-2270-2026

Official wording

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

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.