HIGH

B Braun Medical Recall Expands for Epidural Tray and Catheter Over Lid Positioning Issue (2025)

B BRAUN MEDICAL INC recalls 2,760 units nationwide due to a lid misalignment risk in the catheter connector. The recall covers the PERIFIX FX Continuous Epidural Anesthesia Tray and related components. Healthcare providers should halt use and follow manufacturer instructions for recall remedies.

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, 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 medical device used in anesthesia administration during procedures requiring epidural analgesia. It is distributed nationwide to healthcare facilities.

Why This Is Dangerous

A lid misalignment can affect catheter connection integrity and potentially impact drug delivery during anesthesia.

Industry Context

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

Real-World Impact

The immediate impact is restricted to clinical use and may affect procedural safety until devices are replaced or corrected.

Practical Guidance

How to identify if yours is affected

  1. Identify product CE17TKFS with REF: 332098 and UDI 04046955901067/04046955901074.
  2. Check lot numbers: 00620096222, 0062014350.
  3. Review distribution list for AK-ND etc. (nationwide).

Where to find product info

FDA enforcement page Z-0120-2026 provides recall details.

What timeline to expect

Recall processing timelines vary; follow manufacturer guidance via letter.

If the manufacturer is unresponsive

  • Document all communications
  • Contact FDA if manufacturer fails to provide remedy
  • Request escalation through hospital risk management

How to prevent similar issues

  • Verify lid alignment during setup of similar epidural systems in the future
  • Consult official device labeling and hospital procurement for CE marking compliance
  • Maintain updated SOPs for device verification at point of care

Documentation advice

Keep recall letter, device labels, UDI numbers, lot numbers, and correspondence with manufacturers.

Product Details

Brand: B BRAUN MEDICAL. Product: PERIFIX FX Continuous Epidural Anesthesia Tray and PERIFIX 17 Ga. x 3-1/2 in. Tuohy Epidural Needle Winged; 19 Ga. Open tip PERIFIX FX Springwound Epidural Catheter. Model/Code: CE17TKFS. REF: 332098. UDI-DI (Primary): 04046955901067. UDI-DI (Unit of Use): 04046955901074. Lot Numbers: 00620096222, 0062014350. Product Code: CE17TKFS. 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.

Reported Incidents

No specific injuries or incidents are cited in the recall notice.

Key Facts

  • 2,760 total units recalled
  • Class II device
  • Recall date: 2025-09-18
  • Notice date: 2025-10-15
  • Hazard level: HIGH
View Original Recall on FDA - Medical Devices

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Safety Guide

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Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERALPREGNANTPREGNANTPREGNANT
Injury Types
LACERATIONELECTRICALOTHER

Product Classification

Product TypeEpidural Tray and Catheter
Sold At
Unknown

Product Details

Model Numbers
CE17TKFS
REF: 332098
UDI-DI 04046955901067
UDI-DI Unit of Use 04046955901074
Affected States
ALL
Report Date
October 15, 2025
Recall Status
ACTIVE

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