The Recall Desk
HighFDA (Devices)·Z-0120-2026·Announced 2025-10-15

PERIFIX FX Epidural Anesthesia Tray Recalled for Catheter Connector Positioning Defect

B Braun is recalling 2,760 units of PERIFIX FX Continuous Epidural Anesthesia Trays due to a potential defect where the catheter connector lid may be positioned incorrectly, which could affect proper catheter connector 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 FDA Class II recall involves a risk-of-harm product (epidural anesthesia tray) with a potential defect in catheter connector positioning. No illnesses, injuries, or hospitalizations are reported in the source material. Per the rubric, this qualifies as Score 3 (High) for a 'risk-of-harm product where injury has not yet been reported.'

Plain-English summary

B Braun Medical Inc is recalling 2,760 units of the PERIFIX FX Continuous Epidural Anesthesia Tray nationwide. The recall affects Product Code CE17TKFS, and the affected lot numbers are 0062009622 and 0062014350, which expire July 31, 2026.

The recalled product contains a 17-gauge Tuohy epidural needle and a 19-gauge open-tip springwound epidural catheter. A defect has been identified where the lid of the catheter connector may be in an incorrect position, potentially affecting the proper function of the catheter connector.

Healthcare providers and medical facilities that have received these products should immediately check their inventory against the affected lot numbers. Any units matching the recalled lot numbers should be quarantined and not used. Healthcare providers should contact B Braun or the FDA for instructions on product return or replacement.

The recalled product

Product
PERIFIX FX Continuous Epidural Anesthesia Tray, 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: CE17TKFS. Product Description: CE17TKFS EPIDURAL TRAY.
Manufacturer
B BRAUN MEDICAL INC
Category
Medical Device — Anesthesia Equipment
Hazard
  • device-malfunction
  • assembly-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 (6)

  • REF: 332098
  • Product Code: CE17TKFS
  • UDI-DI (Primary): 04046955901067
  • UDI-DI (Unit of Use): 04046955901074
  • Lot Numbers: 0062009622
  • 0062014350. Expiration Date: 07/31/2026.

Distribution

Distributed nationwide across the United States.

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