Z-0120-2026 Class II Ongoing
FDA device recall Z-0120-2026 was initiated by B BRAUN MEDICAL INC on September 18, 2025 and is designated Class II. Reason for recall: Potential for the lid of the catheter connector to be in the incorrect position. The recall status is ongoing. Affected quantity: 2,760 units.
Recall Details
- Product Type
- Devices
- Report Date
- October 15, 2025
- Initiation Date
- September 18, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,760 units
Product Description
PERIFIX FX Continuous Epidural Anesthesia Tray, PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle - Winged and 19 Ga. Open tip PERIFIX FX Springwound Epidural Catheter. Product Code: CE17TKFS. Product Description: CE17TKFS EPIDURAL TRAY.
Reason for Recall
Potential for the lid of the catheter connector to be in the incorrect position.
Distribution Pattern
Nationwide distribution to AK, AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV.
Code Information
REF: 332098; Product Code: CE17TKFS; UDI-DI (Primary): 04046955901067; UDI-DI (Unit of Use): 04046955901074; Lot Numbers: 0062009622, 0062014350. Expiration Date: 07/31/2026.