B Braun Medical recalls the PERIFIX FX Continuous Epidural Anesthesia Set and PERIFIX Tuohy Epidural Needle nationwide after a lid-position defect is identified. The issue involves the lid of the catheter connector being in the incorrect position. Healthcare providers are advised to stop using the device and follow the manufacturer’s 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 Continuous Epidural Anesthesia Set is used for delivering epidural anesthesia during procedures. It includes a Tuohy needle and a catheter assembly designed for sterile, single-use clinical use.
A lid-position defect in the catheter connector could compromise connection integrity and delivery of anesthetic agents, posing safety risks during procedures.
This recall is not described as part of a broader industry pattern in the provided information.
For patients undergoing epidural anesthesia, a mispositioned connector lid could affect drug delivery and patient safety. Healthcare facilities must halt use until instructed otherwise.
Recall notification letters and the FDA enforcement page provide official guidance and contact details.
Manufacturer guidance will specify replacement or remedy timelines; no specific window is provided in the recall notice.
Keep recall letters and correspondence, preserve affected product batches, photograph labels and serial numbers, maintain propersale and purchase records for potential reimbursement
Model numbers and identifiers: CE17TFC; REF 332238; UDI-DI (Primary) 04046964178603; UDI-DI (Unit of Use) 04046964178597; Lot Number 0062014626. 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. Sold through healthcare channels; no consumer device retail listing provided. Recall date: 2025-09-18. Status: ACTIVE. Remedy: Stop using the device immediately and follow recall instructions. Supplier: B Braun Medical Inc.
No injuries or incidents have been reported.
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