Z-0120-2026 Class II Ongoing

Recalled by B BRAUN MEDICAL INC — Allentown, PA

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.