HIGH

B Braun Medical Recalls Epidural Anesthesia Tray Over Hazard

B Braun Medical recalled the PERIFIX FX Continuous Epidural Anesthesia Tray on September 18, 2025. The manufacturer identified a potential issue with the catheter connector lid position. No injuries have been reported, but users should stop using the product immediately.

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

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

Product Details

The recall affects the PERIFIX FX Continuous Epidural Anesthesia Tray, Product Code: CE17TKF. It includes a PERIFIX 17 Ga. x 3-1/2 in. Tuohy Epidural Needle and a 19 Ga. Open tip PERIFIX FX Springwound Epidural Catheter. The product was distributed nationwide.

The Hazard

The recall stems from a potential risk where the lid of the catheter connector may be incorrectly positioned. This can lead to complications during procedures.

Reported Incidents

As of now, there are no reported injuries associated with this recall. However, the potential hazard poses a significant risk to patients if the device is used.

What to Do

Stop using the device immediately. Follow the recall instructions provided by the manufacturer and contact B Braun Medical or your healthcare provider for further instructions.

Contact Information

For more information, contact B Braun Medical Inc. at their official website or the FDA's recall hotline. Notification was made via letter.

Key Facts

  • Product Code: CE17TKF
  • Nationwide distribution
  • No reported injuries
  • Stop-use recommendation issued
View Original Recall on FDA - Medical Devices

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Safety Assessment

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

Product Classification

Product TypeEpidural Anesthesia Tray
Sold At
Multiple Retailers

Product Details

Model Numbers
REF: 332086
Product Code: CE17TKF
UDI-DI (Primary): 04046955900985
UDI-DI (Unit of Use): 04046955900992
Lot Number: 0062011669
Affected States
ALL
Report Date
October 15, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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