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 an unspecified number of units due to a potential connector misalignment. This issue poses a high risk to patient safety and requires immediate action from healthcare providers.

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

Product Details

The recalled product is the PERIFIX FX Continuous Epidural Anesthesia Tray, including a 17 Ga. x 3-1/2 in. Tuohy Epidural Needle and a 19 Ga. open tip catheter. The product code is CE17TKFSDT. It was distributed nationwide to several states, including California, New York, and Texas.

The Hazard

The recall stems from a potential misalignment of the lid on the catheter connector. This defect can lead to improper functioning of the device during medical procedures, potentially jeopardizing patient safety.

Reported Incidents

As of this recall, no specific incidents, injuries, or deaths have been reported related to this issue. The severity of the hazard is classified as high due to the potential consequences during medical procedures.

What to Do

Healthcare providers and patients must stop using the device immediately. They should follow the recall instructions provided by B Braun Medical and contact their healthcare provider for further guidance.

Contact Information

For more information, contact B Braun Medical Inc. at 1-800-432-1709 or visit their website at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0118-2026.

Key Facts

  • Product code: CE17TKFSDT
  • Class II recall
  • Nationwide distribution
  • Stop using immediately
  • Contact B Braun for guidance
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 TypeAnesthesia Tray
Sold At
Unknown

Product Details

Model Numbers
Product Code: CE17TKFSDT
REF: 332093
UDI-DI (Primary): 04046964954252
UDI-DI (Unit of Use): 04046964954245
Lot Number: 0062003112
Affected States
ALL
Report Date
October 15, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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