PERIFIX FX Epidural Anesthesia Sets Recalled Due to Catheter Connector Positioning Defect
B. Braun Medical recalls PERIFIX FX Continuous Epidural Anesthesia Sets due to a potential defect where the catheter connector lid may be positioned incorrectly.
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: This is an FDA Class II medical device recall. No illnesses or injuries have been reported. The hazard is a mechanical defect involving improper positioning of the catheter connector lid, which is a risk-of-harm scenario without documented injury.
Plain-English summary
B. Braun Medical Inc. is recalling PERIFIX FX Continuous Epidural Anesthesia Sets (Product Code CE17TFC, Lot Number 0062014626, Expiration Date 05/31/2028). The set includes a 17-gauge Tuohy Epidural Needle and 19-gauge Springwound Epidural Catheter.
The recalled sets have a potential defect in which the lid of the catheter connector may be positioned incorrectly.
The affected products were distributed nationwide to healthcare facilities across all U.S. states.
Healthcare providers who have these products should contact B. Braun Medical Inc. for further guidance and instructions on returning or replacing the affected units.
The recalled product
- 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.
- Manufacturer
- B BRAUN MEDICAL INC
- Category
- Medical Device
- Hazard
- catheter-connector-positioning
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: 332238
- Product Code: CE17TFC
- UDI-DI (Primary): 04046964178603
- UDI-DI (Unit of Use): 04046964178597
- Lot Number: 0062014626. Expiration Date: 05/31/2028.
Distribution
Distributed nationwide across the United States.
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