B BRAUN MEDICAL INC recalls 2,760 units nationwide due to a lid misalignment risk in the catheter connector. The recall covers the PERIFIX FX Continuous Epidural Anesthesia Tray and related components. Healthcare providers should halt use and follow manufacturer instructions for recall remedies.
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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This is a medical device used in anesthesia administration during procedures requiring epidural analgesia. It is distributed nationwide to healthcare facilities.
A lid misalignment can affect catheter connection integrity and potentially impact drug delivery during anesthesia.
This recall is not identified as part of a broader industry pattern.
The immediate impact is restricted to clinical use and may affect procedural safety until devices are replaced or corrected.
FDA enforcement page Z-0120-2026 provides recall details.
Recall processing timelines vary; follow manufacturer guidance via letter.
Keep recall letter, device labels, UDI numbers, lot numbers, and correspondence with manufacturers.
Brand: B BRAUN MEDICAL. Product: PERIFIX FX Continuous Epidural Anesthesia Tray and PERIFIX 17 Ga. x 3-1/2 in. Tuohy Epidural Needle Winged; 19 Ga. Open tip PERIFIX FX Springwound Epidural Catheter. Model/Code: CE17TKFS. REF: 332098. UDI-DI (Primary): 04046955901067. UDI-DI (Unit of Use): 04046955901074. Lot Numbers: 00620096222, 0062014350. Product Code: CE17TKFS. 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.
No specific injuries or incidents are cited in the recall notice.
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