HIGH

B Braun Medical PERIFIX FX Epidural Tray Recalled for Lid Misalignment in 48,110 Units (2025)

B Braun Medical Inc. recalled 48,110 units of the PERIFIX FX Continuous Epidural Anesthesia Tray nationwide to hospitals and surgical centers. The recall cites a potential for the lid of the catheter connector to be in the incorrect position. Hospitals and clinics should stop using the device and contact B Braun Medical for instructions.

Quick Facts at a Glance

Recall Date
September 18, 2025
Hazard Level
HIGH
Brand
B Braun Medical
Category
Health & Personal Care
Sold At
Unknown
Geographic Scope
1 states
At-Risk Groups
GENERAL, GENERAL, PREGNANT

Hazard Information

Potential for the lid of the catheter connector to be in the incorrect position.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact B BRAUN MEDICAL INC or your healthcare provider for instructions. Notification method: Letter

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About This Product

The PERIFIX FX Continuous Epidural Anesthesia Tray includes a Tuohy needle and a closed-tip epidural catheter used in anesthesia. Hospitals and surgical centers acquire these trays for neuraxial anesthesia procedures.

Why This Is Dangerous

A mispositioned lid on the catheter connector can compromise the integrity of the connection, potentially affecting drug delivery or safety during use.

Industry Context

This recall is not described as part of a broader industry pattern.

Real-World Impact

Hospitals and clinics must verify device identifiers and ensure any recalled units are removed from use to prevent potential procedure-related complications.

Practical Guidance

How to identify if yours is affected

  1. Check model CE17TKFC and REF 332079 on the device label.
  2. Match UDI Primary 04046955899456 or Unit of Use 04046955899463 to the recall list.
  3. Review lot numbers listed for affected units (0062010541, 0062010542, 0062010543, 0062010545, 0062010546, 0062010547, 0062010548, 0062010549, 0062010550, 0062010743, 0062013041, 0062013042, 0062013043, 0062013044, 0062013045, 0062013046).

Where to find product info

Recall notices are posted on the FDA enforcement page and the manufacturer’s recall communications.

What timeline to expect

Remedial steps for hospitals follow internal procurement and vendor processes. Individual refund or replacement timelines vary by facility.

If the manufacturer is unresponsive

  • Document all contact attempts with the manufacturer.
  • Escalate to FDA recall contacts if the supplier is nonresponsive.
  • Keep all correspondence for records.

How to prevent similar issues

  • Verify connector lid position before use when applicable.
  • Review future shipments for proper labeling and lid integrity.
  • Ask suppliers for device-specific incident reports and recall history prior to purchase.

Documentation advice

Keep the recall letter, correspondences with the manufacturer, model numbers, UDI codes, and lot numbers for future reference.

Product Details

Model numbers: CE17TKFC; REF: 332079 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: Nationwide to AK, AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV Quantity: 48,110 units Sold At: Unknown

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • 48,110 units recalled
  • Nationwide distribution to multiple states
  • Model CE17TKFC; UDI 04046955899456/04046955899463
  • Lot numbers include 0062010541-0062010549, 0062010743, 0062013041-0062013046
  • Recall Date: 2025-09-18
  • Hazard: lid misalignment in catheter connector

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
7/ 10
Affected Groups
GENERALGENERALPREGNANTPREGNANT
Injury Types
OTHER

Product Classification

Product Details

Model Numbers
CE17TKFC
REF: 332079
0062010541
0062010542
0062010543
+13 more
Affected States
ALL
Report Date
October 15, 2025
Recall Status
ACTIVE

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