HIGH

B Braun Medical Recalls Epidural Anesthesia Tray Over Connector Issue

B Braun Medical recalled the PERIFIX FX Continuous Epidural Anesthesia Tray on September 18, 2025. The recall affects a potential defect in the catheter connector lid. Patients and healthcare providers 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 involves the PERIFIX FX Continuous Epidural Anesthesia Tray with product code CE17TKFCPS. The tray includes a 17 Ga. x 3-1/2 in. Tuohy epidural needle and a 19 Ga. closed tip epidural catheter. The affected products were distributed nationwide.

The Hazard

The potential hazard involves the lid of the catheter connector being incorrectly positioned. This malfunction can lead to improper use during epidural anesthesia.

Reported Incidents

There are no reported incidents associated with this recall, but the risk is classified as high due to potential complications in anesthesia administration.

What to Do

Stop using the device immediately. Contact B Braun Medical or your healthcare provider for further instructions and follow the recall notifications.

Contact Information

For more information, contact B Braun Medical at the provided customer service number. Visit the FDA's website for additional details.

Key Facts

  • Product Code: CE17TKFCPS
  • Recall Date: September 18, 2025
  • Hazard Level: High
  • Distributed nationwide in the U.S.

Safety Assessment

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

Product Classification

Product Details

Model Numbers
REF: 332078
Product Code: CE17TKFCPS
UDI-DI (Primary): 04046955899432
UDI-DI (Unit of Use): 04046955899449
Lot Numbers: 0062006314
+2 more
Affected States
ALL
Report Date
October 15, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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