HIGH

B. Braun Medical Recalls 5,770 PERIFIX FX Epidural Anesthesia Trays for Lid Position Issue

B BRAUN MEDICAL INC recalls 5,770 PERIFIX FX Epidural Anesthesia Trays nationwide after a potential lid misalignment in the catheter connector. The issue could affect catheter administration. Stop using the device and follow recall instructions immediately. Healthcare providers should contact B Braun for guidance.

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, PREGNANT, PETS

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

PERIFIX FX Epidural Anesthesia Tray is used to prepare and deliver epidural anesthesia in surgical settings.

Why This Is Dangerous

A lid position issue in the catheter connector could impact safe administration of anesthesia under clinical conditions.

Industry Context

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

Real-World Impact

Immediate action required to avoid potential misalignment during procedures; no injuries reported yet.

Practical Guidance

How to identify if yours is affected

  1. Check product refs listed in recall: REF 551028, 551474, 551630, 551749, 551769, 551998
  2. Verify packaging and labeling match recall notices
  3. Review purchase history and shipment records

Where to find product info

Recall notification by mail and FDA enforcement page Z-0126-2026

What timeline to expect

Replacement or refund guidance will be provided by manufacturer; typical timelines are several weeks

If the manufacturer is unresponsive

  • Document all communications
  • Escalate to FDA or consumer protection agencies if needed
  • Consider legal advice for unresponsive manufacturers

How to prevent similar issues

  • Verify device compatibility in hospital inventory systems
  • Maintain updated recall contact information for suppliers
  • Establish internal checklists to verify connector lids before use

Documentation advice

Keep recall notices, model refs, and correspondence; photograph product and labels

Product Details

Brand: B BRAUN MEDICAL. Product: PERIFIX FX Epidural Anesthesia Tray. Product Codes/Refs: REF: 551028, 551474, 551630, 551749, 551769, 551998. Distribution: Nationwide to 34 states listed in recall notice (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: 5,770 units.

Reported Incidents

No specific injuries or incidents are mentioned in the provided recall notice.

Key Facts

  • 5,770 units recalled
  • Nationwide distribution to AK through WV
  • High hazard level
  • Product refs: REF: 551028, 551474, 551630, 551749, 551769, 551998
  • Recall date 2025-09-18
  • Status: ACTIVE
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
GENERALPREGNANTPETS
Injury Types
LACERATIONELECTRICALSUFFOCATIONOTHERBURN

Product Classification

Product TypeEpidural Anesthesia Tray
Sold At
Unknown

Product Details

Model Numbers
REF: 551028
REF: 551474
REF: 551630
REF: 551749
REF: 551769
+1 more
Affected States
ALL
Report Date
October 15, 2025
Recall Status
ACTIVE

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