HIGH

B Braun Medical Issues Recall for Epidural Anesthesia Tray Due to Connector Hazard

B Braun Medical recalled 2,760 units of its PERIFIX FX Continuous Epidural Anesthesia Tray on September 18, 2025. The recall stems from a potential misalignment of the catheter connector lid, posing a high risk to patients. Healthcare providers and patients must stop using the device immediately and follow the manufacturer’s instructions.

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 recalled product is the PERIFIX FX Continuous Epidural Anesthesia Tray, featuring a 17 Ga. x 3-1/2 in. Tuohy Epidural Needle and a 19 Ga. Open tip Epidural Catheter. The product code is CE17TKFS. The tray was distributed nationwide across various states.

The Hazard

The potential hazard involves the lid of the catheter connector being in the incorrect position. This misalignment can lead to serious complications during epidural procedures.

Reported Incidents

No specific incidents or injuries have been reported to date. However, the potential risks associated with the misalignment warrant immediate attention.

What to Do

Patients and healthcare providers should stop using the device immediately. Contact B Braun Medical or your healthcare provider for further instructions and follow the recall process as outlined in the notification letter.

Contact Information

For more information, contact B Braun Medical Inc. at their official website or call their customer service.

Key Facts

  • Recall date: September 18, 2025
  • Class II recall
  • Affected product code: CE17TKFS
  • Quantity recalled: 2,760 units
  • Nationwide distribution in the U.S.
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
REF: 332098
Product Code: CE17TKFS
UDI-DI (Primary): 04046955901067
UDI-DI (Unit of Use): 04046955901074
Lot Numbers: 00620096222
+1 more
Affected States
ALL
Report Date
October 15, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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