HIGH

B Braun Medical Perifix FX Epidural Tray Recall for Lid Misalignment in Catheter Connector

B Braun Medical has an active recall of the PERIFIX FX Continuous Epidural Anesthesia Tray nationwide. The recall cites a potential mispositioned catheter connector lid. Healthcare providers and patients should stop using the device and follow manufacturer instructions.

Quick Facts at a Glance

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

This is a sterile medical device used for continuous epidural anesthesia. It includes an epidural needle and catheter within a tray setup for clinical use.

Why This Is Dangerous

A lid misalignment could compromise catheter connector integrity, potentially impacting sterile connection and delivery.

Industry Context

This recall is not described as part of a broader industry-wide pattern in the provided data.

Real-World Impact

Immediate discontinuation of use is required. No injuries reported yet, but potential for device malfunction requires medical oversight.

Practical Guidance

How to identify if yours is affected

  1. Verify product code CE17TKFCPS
  2. Confirm UDI primary 04046955899432
  3. Check Unit of Use 04046955899449
  4. Inspect lot numbers 0062006314, 0062011670, 0062028428

Where to find product info

Identifier labels are on the tray and packaging; UDI and lot numbers are printed on the labeling and unit packaging.

What timeline to expect

Refunds or replacements follow manufacturer instructions via notification letters; timelines not specified.

If the manufacturer is unresponsive

  • Escalate to hospital procurement or device representative
  • File a formal complaint with the FDA if needed

How to prevent similar issues

  • Verify device labeling matches recall information before use
  • Store affected lots separately and quarantine unused units
  • Follow standard sterile processing and device recall protocols

Documentation advice

Keep recall notices, product packaging, lot numbers, and correspondence with supplier.

Product Details

Brand: B BRAUN MEDICAL. Product: PERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga. x 3-1/2 in. Tuohy Epidural Needle Winged and 19 Ga. Closed tip PERIFIX FX Springwound Epidural Catheter. Product Code CE17TKFCPS. Model references include REF: 332078, UDI-DI primary 04046955899432 and Unit of Use 04046955899449. Lot numbers include 0062006314, 0062011670, 0062028428. Distribution: Nationwide across 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.

Reported Incidents

No injuries or incidents have been reported in the provided data.

Key Facts

  • HIGH hazard level
  • Class II device
  • Active recall as of 2025-10-15
  • Product Code CE17TKFCPS
  • UDIs: 04046955899432 (primary), 04046955899449 (unit of use)
View Original Recall on FDA - Medical Devices

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Safety Guide

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERALPREGNANTPREGNANTELDERLY
Injury Types
ELECTRICALOTHER

Product Classification

Product TypeEpidural anesthesia tray and catheter set

Product Details

Model Numbers
CE17TKFCPS
REF: 332078
Affected States
ALL
Report Date
October 15, 2025
Recall Status
ACTIVE

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