PERIFIX FX Epidural Anesthesia Tray Catheter Connector Lid Recall
B. Braun is recalling PERIFIX FX epidural anesthesia trays due to a potential defect where the catheter connector lid may be in the incorrect position. This affects lot 0062011669 distributed nationwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall with a potential defect in a critical component of an epidural anesthesia tray. No illnesses, injuries, or hospitalizations have been reported. The hazard is risk-of-harm but theoretical.
Plain-English summary
B. Braun Medical Inc. is recalling PERIFIX FX Continuous Epidural Anesthesia Trays nationwide. The product includes a PERIFIX 17 gauge x 3-1/2 inch Tuohy epidural needle and 19 gauge PERIFIX FX Springwound epidural catheter, with Product Code CE17TKF.
The recall is due to a potential defect where the lid of the catheter connector may be in the incorrect position. An improperly positioned connector lid could compromise the proper assembly and function of the epidural tray.
The affected lot number is 0062011669, with an expiration date of July 31, 2026. Distribution was nationwide, across all states. Healthcare facilities and medical professionals should check their inventory for this specific lot number and contact B. Braun Medical Inc. for further guidance.
The recalled product
- 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
- Manufacturer
- B BRAUN MEDICAL INC
- Hazard
- connector-misposition
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- REF: 332086
- Product Code: CE17TKF
- UDI-DI (Primary): 04046955900985
- UDI-DI (Unit of Use): 04046955900992
- Lot Number: 0062011669. Expiration Date: 07/31/2026.
Distribution
Distributed nationwide across the United States.
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