B Braun Medical Inc. recalled 48,110 units of the PERIFIX FX Continuous Epidural Anesthesia Tray nationwide to hospitals and surgical centers. The recall cites a potential for the lid of the catheter connector to be in the incorrect position. Hospitals and clinics should stop using the device and contact B Braun Medical for instructions.
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
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The PERIFIX FX Continuous Epidural Anesthesia Tray includes a Tuohy needle and a closed-tip epidural catheter used in anesthesia. Hospitals and surgical centers acquire these trays for neuraxial anesthesia procedures.
A mispositioned lid on the catheter connector can compromise the integrity of the connection, potentially affecting drug delivery or safety during use.
This recall is not described as part of a broader industry pattern.
Hospitals and clinics must verify device identifiers and ensure any recalled units are removed from use to prevent potential procedure-related complications.
Recall notices are posted on the FDA enforcement page and the manufacturer’s recall communications.
Remedial steps for hospitals follow internal procurement and vendor processes. Individual refund or replacement timelines vary by facility.
Keep the recall letter, correspondences with the manufacturer, model numbers, UDI codes, and lot numbers for future reference.
Model numbers: CE17TKFC; REF: 332079 UDI-DI (Primary): 04046955899456 UDI-DI (Unit of Use): 04046955899463 Lot Numbers: 0062010541, 0062010542, 0062010543, 0062010545, 0062010546, 0062010547, 0062010548, 0062010549, 0062010550, 0062010743, 0062013041, 0062013042, 0062013043, 0062013044, 0062013045, 0062013046 Distribution: Nationwide to AK, AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV Quantity: 48,110 units Sold At: Unknown
No injuries or incidents have been reported.
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