Z-2265-2026 Class II Ongoing
FDA device recall Z-2265-2026 was initiated by B Braun Medical Inc on January 29, 2026 and is designated Class II. Reason for recall: 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 t… The recall status is ongoing. Affected quantity: 1730.
Recall Details
- Product Type
- Devices
- Report Date
- June 10, 2026
- Initiation Date
- January 29, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1730
Product Description
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
Reason for Recall
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.
Distribution Pattern
US Nationwide distribution in the states of AL, FL, PA, TX, VA, WA.
Code Information
Lot Code: Model No 530201, UDI-DI (Primary Device) 04046955672196, UDI-DI (Unit Device ID) 04046955672189, Lot Number 0062010965