Recall Z-0117-2026— B BRAUN MEDICAL INC

Name: FDA recall Z-0117-2026
Creator: U.S. Food and Drug Administration
Published: 2025-09-18

Class II · Ongoing

Class II FDA medical device recall by B BRAUN MEDICAL INC, initiated 2025-09-18. FDA's recall record names no specific 510(k) clearance for this event. Product: PERIFIX FX Continuous Epidural Anesthesia Tray with 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: CE17TKF. Product Description: CE17TKF PERIFIX CONTIN. EPIDURAL TRAY. Reason: Potential for the lid of the catheter connector to be in the incorrect position..

Recalling firm: B BRAUN MEDICAL INC
Classification: Class II
Status: Ongoing
Initiated: 2025-09-18
Firm location: Allentown, PA, United States

Product description

PERIFIX FX Continuous Epidural Anesthesia Tray with 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: CE17TKF. Product Description: CE17TKF PERIFIX CONTIN. EPIDURAL TRAY

Reason for recall

Potential for the lid of the catheter connector to be in the incorrect position.

Data sourced from openFDA. This site is unofficial and independent of the FDA.