The Recall Desk
HighFDA (Devices)·Z-0116-2026·Announced 2025-10-15

PERIFIX FX Epidural Anesthesia Tray Connector Lid Misalignment Recall

B. Braun is recalling 48,110 units of PERIFIX FX Continuous Epidural Anesthesia Trays because the catheter connector lid may be positioned incorrectly, potentially affecting proper catheter function during procedures.

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 Class II medical device recall with a potential mechanical defect in the catheter connector lid. No illnesses or injuries have been reported. The defect could pose a risk during epidural anesthesia procedures, but the hazard remains theoretical pending actual adverse events.

Plain-English summary

B. Braun Medical Inc. is recalling 48,110 units of the PERIFIX FX Continuous Epidural Anesthesia Tray nationwide due to a potential defect in the catheter connector lid.

The recalled product is the PERIFIX FX Continuous Epidural Anesthesia Tray (Product Code: CE17TKFC), which includes a PERIFIX 17 Ga. x 3-1/2 in. Tuohy Epidural Needle and a 19 Ga. Closed tip PERIFIX FX Springwound Epidural Catheter. The recall affects 22 specific lot numbers, all with an expiration date of July 31, 2026.

The issue is that the lid of the catheter connector may be positioned incorrectly. This defect could potentially compromise the proper function of the catheter during epidural anesthesia procedures.

Patients and healthcare providers who have received or used these trays should contact B. Braun Medical Inc. or their healthcare provider for further guidance. The FDA classified this as a Class II recall.

The recalled product

Product
PERIFIX FX Continuous Epidural Anesthesia Tray with 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: CE17TKFC. Product Description: CE17TKFC EPIDURAL TRAY W/ 17GA TUOHY.
Manufacturer
B BRAUN MEDICAL INC
Category
Medical Device — Epidural Anesthesia Equipment
Hazard
  • connector-misalignment

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 (20)

  • REF: 332079
  • Product Code: CE17TKFC
  • UDI-DI (Primary): 04046955899456
  • UDI-DI (Unit of Use): 04046955899463
  • Lot Numbers: 0062010541
  • 0062010542
  • 0062010543
  • 0062010545
  • 0062010546
  • 0062010547
  • 0062010548
  • 0062010549
  • 0062010550
  • 0062010743
  • 0062013041
  • 0062013042
  • 0062013043
  • 0062013044
  • 0062013045
  • 0062013046

Distribution

Distributed nationwide across the United States.

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