B Braun Medical recalled the PERIFIX FX Continuous Epidural Anesthesia Tray nationwide. The recall centers on the lid of the catheter connector that may be in the incorrect position. Patients and healthcare providers should stop using the device immediately and follow recall 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 tray is a medical device used in continuous epidural anesthesia. It includes a Tuohy needle and an open-tip catheter for placement and infusion during procedures.
A lid misposition on the catheter connector can compromise the integrity of the connection, potentially affecting sterile barriers and flow pathways.
This recall is not part of a broader industry pattern.
Hospitals may need to stop using affected kits and replace them. No injuries have been reported so far, but rapid action is required to avoid potential complications.
On product labeling and the FDA recall page for Z-0117-2026.
Refunds or replacements may take several weeks after submission.
Keep recall notification, photos of labels and packaging, record product code CE17TKF, UDIs, lot numbers, and all correspondence.
Model numbers: CE17TKF, REF: 332086. UDI-DI (Primary): 04046955900985. UDI-DI (Unit of Use): 04046955900992. Lot Number: 0062011669. 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: 0 units. Product Code: CE17TKF. Seller/Manufacturer: B Braun Medical Inc. Sold at: Not specified. Recall Date: 2025-09-18. Status: ACTIVE. Classification: Class II.
No injuries or incidents have been reported.
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