Recall Z-0121-2026— B BRAUN MEDICAL INC

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 Set, PERIFIX Tuohy Epidural Needle - 17 Ga. x 3-1/2 in. (8.9 cm) - Winged, PERIFIX FX Springwound Epidural Catheter - 19 Ga. Closed tip. Product Code: CE17TFC. Product Description: CE17TFC CONTINUOUS EPID SET W/17G TUOHY.. 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 Set, PERIFIX Tuohy Epidural Needle - 17 Ga. x 3-1/2 in. (8.9 cm) - Winged, PERIFIX FX Springwound Epidural Catheter - 19 Ga. Closed tip. Product Code: CE17TFC. Product Description: CE17TFC CONTINUOUS EPID SET W/17G TUOHY.

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.