B Braun Medical distributed nationwide a recall of its CE17TKFSDT epidural tray kit. The hazard involves the catheter connector lid potentially being in the incorrect position. Healthcare providers should stop using the device and follow recall instructions from the manufacturer.
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 CE17TKFSDT is an epidural anesthesia tray intended for clinical use. It includes a 17 Ga Tuohy needle with fixed wings and a 19 Ga Open Tip Epidural Catheter. Healthcare settings use these components together during neuraxial anesthesia.
If the catheter connector lid is not in the correct position, the connection may not seal properly or may misalign during use, potentially affecting catheter performance.
This recall is not described as part of a broader industry pattern in the provided notice.
In clinical settings, any lid misposition could compromise catheter integrity, potentially impacting anesthesia administration and patient safety. Hospitals should identify affected lots and replace or repair as directed.
Details are available on the FDA recall enforcement page for Z-0118-2026 and through the manufacturer’s recall communications.
Manufacturers generally complete replacements or refunds within weeks to months depending on facility and stock.
Keep copy of recall notice, the lot number, and correspondence with the manufacturer. Document any replacements or instructions given by clinicians.
Product: PERIFIX FX Continuous Epidural Anesthesia Tray with 17 Ga Tuohy Needle (3-1/2 in) fixed wings and 19 Ga Open Tip Epidural Catheter. Product Code: CE17TKFSDT. REF: 332093. UDI-DI Primary: 04046964954252. UDI-DI Unit of Use: 04046964954245. Lot Number: 0062003112. Sold 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. Distributor: B Braun Medical. Price: Unknown.
No injuries or incidents have been reported.
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