HIGH

B Braun Medical Recalls Epidural Anesthesia Tray Due to Hazard

B Braun Medical recalled 48,110 epidural anesthesia trays on September 18, 2025. The recall stems from a potential issue with the catheter connector lid. Healthcare providers and patients must stop using the device 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 with model code CE17TKFC. It includes a 17 Ga. x 3-1/2 in. Tuohy Epidural Needle and a 19 Ga. Closed tip Epidural Catheter. The trays were distributed nationwide to various states.

The Hazard

There is a potential for the lid of the catheter connector to be in the incorrect position. This defect poses a risk of improper drug delivery, which can lead to serious complications.

Reported Incidents

As of now, there have been no reported injuries or adverse events linked to this hazard. The risk level is classified as high due to the potential for serious complications.

What to Do

Patients and healthcare providers should stop using the device immediately. They should follow the recall instructions provided by the manufacturer and contact B Braun Medical or their healthcare provider for further instructions.

Contact Information

For more details, contact B Braun Medical at 1-800-xxx-xxxx or visit their website for additional instructions.

Key Facts

  • 48,110 units recalled
  • Potential issue with catheter connector lid
  • No injuries reported
  • Immediate stop-use recommended
  • Nationwide distribution across multiple states
View Original Recall on FDA - Medical Devices

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Safety Assessment

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

Product Classification

Product TypeEpidural Anesthesia Tray
Sold At
Multiple Retailers

Product Details

Model Numbers
CE17TKFC
REF: 332079
UDI-DI (Primary): 04046955899456
UDI-DI (Unit of Use): 04046955899463
Lot Numbers: 0062010541
+15 more
Affected States
ALL
Report Date
October 15, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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