PERIFIX FX Epidural Anesthesia Tray Catheter Connector Lid Positioning Defect
B BRAUN Medical is recalling PERIFIX FX Continuous Epidural Anesthesia Trays due to a potential manufacturing defect where the catheter connector lid may be positioned incorrectly, which could affect proper drug delivery and catheter function.
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. While no injuries or adverse events have been reported, the product is a risk-of-harm device used in critical epidural anesthesia procedures. A catheter connector lid in an incorrect position could affect proper drug delivery and device function, which warrants a High severity rating per the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
B BRAUN Medical Inc. is recalling PERIFIX FX Continuous Epidural Anesthesia Trays nationwide. The recalled product is a continuous epidural anesthesia tray that includes a PERIFIX 17 Ga. x 3-1/2 inch Tuohy Epidural Needle - Winged and a 19 Ga. Closed tip PERIFIX FX Springwound Epidural Catheter, used to deliver anesthesia and pain relief during medical procedures.
The recall is due to a potential manufacturing defect in certain product lots. Specifically, the lid of the catheter connector may be positioned incorrectly, which could potentially affect the integrity of the drug delivery system and proper catheter function.
The affected lot numbers are 0062006314, 0062011670, and 0062028428 with an expiration date of July 31, 2026. The product was distributed nationwide to healthcare facilities across all U.S. states.
Healthcare providers who have received affected lots should immediately stop using the product and quarantine it. Contact B BRAUN Medical Inc. for instructions regarding replacement or disposal of the affected trays. Any adverse events or product quality issues should be reported to the FDA.
The recalled product
- Product
- PERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga. x 3-1/2 in. (8.9cm) Tuohy Epidural Needle - Winged and 19 Ga. Closed tip PERIFIX FX Springwound Epidural Catheter. Product Code: CE17TKFCPS. Product Description: CE17TKFCPS EPIDURAL FULL TRAY.
- Manufacturer
- B BRAUN MEDICAL INC
- Hazard
- catheter-connector-defect
- drug-delivery-defect
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 (7)
- REF: 332078
- Product Code: CE17TKFCPS
- UDI-DI (Primary): 04046955899432
- UDI-DI (Unit of Use): 04046955899449
- Lot Numbers: 0062006314
- 0062011670
- 0062028428. Expiration Date: 07/31/2026
Distribution
Distributed nationwide across the United States.
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