The Recall Desk
HighFDA (Devices)·Z-0119-2026·Announced 2025-10-15

Epidural Catheter Tray: Connector Lid Positioning Defect

B. Braun Medical is recalling PERIFIX FX Continuous Epidural Anesthesia Trays due to a potential defect where the catheter connector lid may be positioned incorrectly. The recall affects 21,270 units 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 a risk-of-harm product (epidural catheter equipment used in clinical settings) where no injury has yet been reported, meeting the Score 3 criterion. While FDA Class II designation applies, the recall does not report hospitalizations or actual adverse events, which would be required to reach Score 4.

Plain-English summary

B. Braun Medical Inc. is recalling the PERIFIX FX Continuous Epidural Anesthesia Tray, a medical device used to deliver epidural anesthesia in clinical settings. The product (Code: CE17TKFCS) includes a 17 gauge Tuohy epidural needle and a 19 gauge closed-tip springwound epidural catheter. The recall was initiated due to a potential defect in which the lid of the catheter connector may be positioned incorrectly.

The affected units were distributed nationwide across 38 states. The recall encompasses 21,270 units with the following lot numbers: 0062013051, 0062010532, 0062010533, 0062010534, 0062010535, 0062010536, 0062010555, 0062013050, 0062013053, and 0062013052. All affected units have an expiration date of July 31, 2026.

Healthcare facilities and practitioners who possess this product should immediately discontinue use of the affected lot numbers. An incorrectly positioned connector lid could interfere with the proper function and reliability of the epidural catheter. Affected parties should contact B. Braun Medical Inc. for instructions on returning or receiving replacement units.

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. Closed tip PERIFIX FX Springwound Epidural Catheter. Product Code: CE17TKFCS. Product Description: CE17TKFCS CONT EPID TRAY W/17G TUOHY-LF.
Manufacturer
B BRAUN MEDICAL INC
Category
Medical Device — Anesthesia Equipment
Hazard
  • connector-positioning-defect
  • device-malfunction-risk

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 (14)

  • REF: 332097
  • Product Code: CE17TKFCS
  • UDI-DI (Primary): 04046955899470
  • UDI-DI (Unit of Use): 04046955899487
  • Lot Numbers: 0062013051
  • 0062010532
  • 0062010533
  • 0062010534
  • 0062010535
  • 0062010536
  • 0062010555
  • 0062013050
  • 0062013053
  • 0062013052. Expiration Date: 07/31/2026.

Distribution

Distributed nationwide across the United States.

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