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
Product summary
- 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
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.