Recall Z-0118-2026— 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, 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle - Fixed Wings, 19 Ga. Open tip PERIFIX FX Springwound Epidural Catheter. Product Code: CE17TKFSDT. Product Description: CE17TKFSDT EPID TRAY W/17GA FIXED WING.. 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, 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle - Fixed Wings, 19 Ga. Open tip PERIFIX FX Springwound Epidural Catheter. Product Code: CE17TKFSDT. Product Description: CE17TKFSDT EPID TRAY W/17GA FIXED WING.
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.