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B Braun Medical Recall Expands for Perifix FX Epidural Tray and Catheter Over Lid Position Defect (Z

B Braun Medical recalled an epidural anesthesia tray nationwide after finding a lid misalignment in the catheter connector could occur. The recall involves the PERIFIX FX Continuous Epidural Anesthesia Tray and PERIFIX FX Springwound Catheter with a 17 Ga Tuohy needle and 19 Ga closed-tip catheter. The recall date is 2025-09-18 with report of ongoing action as of 2025-10-15. Healthcare providers,,

Official notice
B Braun MedicalHealth & Personal CareMedical DevicesCE17TBFCREF: 332077UDI-DI Primary 4046964177187

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DEVICE
Recall date
September 18, 2025
Status
ACTIVE
Severity
8/10

Quick Facts at a Glance

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

What to Do Now

Use this page like a recall checklist: verify the product first, then act on the official remedy.

Immediate steps

  1. 1Stop using the product until you confirm whether it is included in the recall.
  2. 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
  3. 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
  4. 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.

Check these identifiers

Brand
B Braun Medical
Product type
Epidural Tray with Tuohy Needle and Catheter
Model numbers
CE17TBFC, REF: 332077, UDI-DI Primary 4046964177187, UDI-DI Unit of Use 4046964177170
Sizes
17 Ga x 3-1/2 in. (9 cm) Tuohy needle, 19 Ga closed-tip catheter
Sold at
Multiple Retailers
Where affected
ALL

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    September 18, 2025

  2. Reported by FDA DEVICE

    October 15, 2025

  3. RecallRadar source check

    April 18, 2026

  4. Consumer action

    Use the official remedy and keep documentation.

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

About This Product

The Perifix FX system is used for continuous epidural anesthesia in clinical settings. It includes a Tuohy needle and a springwound catheter for pain management.

Why This Is Dangerous

A lid in the catheter connector that is not correctly positioned could affect the seal and flow, potentially compromising sterile barrier and delivery.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Direct medical procedure impact. Potential delays or complications in anesthesia delivery if used.

Practical Guidance

How to identify if yours is affected

  1. Check if your device corresponds to CE17TBFC with REF 332077 and UDI numbers 4046964177187 and 4046964177170.
  2. Inspect lot 0062022053 and expiration 10/16/2024.
  3. Confirm recall notification from B Braun Medical.

Where to find product info

FDA recall page Z-0114-2026 and manufacturer communications.

What timeline to expect

Refunds or replacements will be arranged via mailed recall communications; process timelines vary by facility.

If the manufacturer is unresponsive

  • Document all communications with the hospital or supplier.
  • Escalate to hospital compliance department or state health authority if the vendor is unresponsive.

How to prevent similar issues

  • Verify LIDS and connectors during installation checks.
  • Use only fresh, non-expired supplies; verify packaging integrity.
  • Follow standard aseptic technique and supplier recall guidance when substituting products.

Documentation advice

Keep recall notices, lot numbers, UDI, and correspondence; photograph the device and packaging.

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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 PERIFIX FX Springwound Catheter - 19 Ga. Closed Tip. Product Code: CE17TBFC. Model codes: REF: 332077; UDI-DI Primary 4046964177187; UDI-DI Unit of Use 4046964177170. Sold/Distributed: Nationwide distribution 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. Recall Date: 2025-09-18. Report Date: 2025-10-15. Hazard: Potential for the lid of a

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • HIGH hazard level
  • Lid position defect in catheter connector
  • Single lot: 0062022053, Expiration 10/16/2024
  • Unit of Use 4046964177170
  • Product Code CE17TBFC

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
8/ 10
Affected Groups
GENERALPREGNANTPREGNANTPETS
Injury Types
ELECTRICALLACERATIONPOISONING

Product Classification

Product Details

Model Numbers
CE17TBFC
REF: 332077
UDI-DI Primary 4046964177187
UDI-DI Unit of Use 4046964177170
Affected States
ALL
Report Date
October 15, 2025
Recall Status
ACTIVE

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