Epidural catheter connector lid may be in incorrect position
B. Braun is recalling PERIFIX FX Continuous Epidural Anesthesia Trays because the catheter connector lid may be incorrectly positioned. The product was 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: This is an FDA Class II medical device recall with a structural defect in the catheter connector. The defect qualifies as a risk-of-harm product—a connector lid in an incorrect position could affect proper device function—and no injuries have been reported.
Plain-English summary
B. Braun Medical Inc. is recalling the PERIFIX FX Continuous Epidural Anesthesia Tray (Product Code: CE17TKFSDT) because of a potential defect in which the catheter connector lid may be in an incorrect position. The product is used for delivering continuous epidural anesthesia.
The affected product was distributed nationwide to healthcare facilities across all 50 states. The recalled lot number is 0062003112, with an expiration date of July 31, 2026.
Healthcare facilities and patients should be aware of this recall. For information regarding this recall or if you have this product, contact B. Braun Medical Inc. for guidance on replacement or return.
The recalled product
- 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.
- Manufacturer
- B BRAUN MEDICAL INC
- Hazard
- catheter-defect
- device-malfunction
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: 332093
- Product Code: CE17TKFSDT
- UDI-DI (Primary): 04046964954252
- UDI-DI (Unit of Use): 04046964954245
- Lot Number: 0062003112. Expiration Date: 07/31/2026.
Distribution
Distributed nationwide across the United States.
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