Recall Z-0119-2026— 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 Tray, PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle - Winged and 19 Ga. Closed tip PERIFIX FX Springwound Epidural Catheter. Product Code: CE17TKFCS. Product Description: CE17TKFCS CONT EPID TRAY W/17G TUOHY-LF.. 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, PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle - Winged and 19 Ga. Closed tip PERIFIX FX Springwound Epidural Catheter. Product Code: CE17TKFCS. Product Description: CE17TKFCS CONT EPID TRAY W/17G TUOHY-LF.

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.