Device product
Brand Name: B. BRAUN MEDICAL INC. Product Name: NES1725KFXL SPINAL EPID CLOSED TIP CATH Model/Catalog Number: 530201 Software Version: N/A Product Description: NES1725KFXL SPINAL EPID CLOSED TIP CATH Component: No
Z-2265-2026
Product summary
- Event
- Event 98862
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1730
- Official record key
device-enforcement:Z-2265-2026
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 530201, UDI-DI (Primary Device) 04046955672196, UDI-DI (Unit Device ID) 04046955672189, Lot Number 0062010965
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.