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.
Potential for the lid of the catheter connector to be in the incorrect position.
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
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 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.
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.
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.
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.
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