HIGH

B BRAUN MEDICAL Recalls Epidural Anesthesia Tray Over Connector Hazard

B BRAUN MEDICAL recalled 21,270 epidural anesthesia trays on September 18, 2025. The recall follows concerns about a potential misalignment of 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, including a 17 Ga. x 3-1/2 in. Tuohy Epidural Needle and a 19 Ga. Closed tip PERIFIX FX Springwound Epidural Catheter. The product code is CE17TKFCS, and it was distributed nationwide.

The Hazard

The lid of the catheter connector may be incorrectly positioned, posing a risk during use. This misalignment could lead to complications in administering anesthesia.

Reported Incidents

No specific incidents or injuries have been reported to date. However, the potential hazard has been classified as high.

What to Do

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

Contact Information

For more information, visit the B BRAUN MEDICAL website or call for support. The recall notification was sent via letter.

Key Facts

  • Recall date: September 18, 2025
  • Quantity recalled: 21,270 units
  • Hazard classification: Class II
  • Expiration date: July 31, 2026
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: 332097
Product Code: CE17TKFCS
UDI-DI (Primary): 04046955899470
UDI-DI (Unit of Use): 04046955899487
Lot Numbers: 0062013051
+9 more
Affected States
ALL
Report Date
October 15, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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