HIGH

B BRAUN MEDICAL Recalls Epidural Anesthesia Set Over Connector Issue

B BRAUN MEDICAL recalled its PERIFIX FX Continuous Epidural Anesthesia Set on September 18, 2025. The recall affects a potential defect in the catheter connector lid position. This high-risk issue could impact patient safety in healthcare settings across the country.

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

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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Product Details

The recalled product is the PERIFIX FX Continuous Epidural Anesthesia Set, including the PERIFIX Tuohy Epidural Needle (17 Ga. x 3-1/2 in.) and the PERIFIX FX Springwound Epidural Catheter (19 Ga. Closed tip). It has product codes CE17TFC and REF: 332238. The device was distributed nationwide.

The Hazard

The recall stems from a potential defect where the lid of the catheter connector may be incorrectly positioned. This issue poses a high risk of complications during epidural anesthesia procedures.

Reported Incidents

As of now, there are no reported injuries or incidents associated with this recall. The company is acting proactively to prevent any potential risks.

What to Do

Stop using the product immediately. Follow the recall instructions provided by B BRAUN MEDICAL. Contact them or your healthcare provider for further guidance.

Contact Information

For more information, visit the B BRAUN MEDICAL website or call their customer service for assistance.

Key Facts

  • Recall date: September 18, 2025
  • Class II medical device recall
  • Potential for connector lid misalignment
  • Nationwide distribution

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Details

Model Numbers
REF: 332238
Product Code: CE17TFC
UDI-DI (Primary): 04046964178603
UDI-DI (Unit of Use): 04046964178597
Lot Number: 0062014626
Affected States
ALL
Report Date
October 15, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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