Class 2 Device Recall CE17TBFC EPIDURAL BASIC TRAY 17G TOUHY.

• Date Initiated by Firm: September 18, 2025
• Date Posted: October 09, 2025
• Recall Status: Open, Classified
• Recall Number: Z-0114-2026
• Recall Event ID: 97550
• Product Classification: Epidural anesthesia kit - Product Code OGE
• Product: PERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga. x 3-1/2 in. (9cm) Tuohy Epidural Needle - Winged and PERIFIX FX Springwound Catheter - 19 Ga. Closed Tip. Product Code: CE17TBFC. Product description: CE17TBFC EPIDURAL BASIC TRAY 17G TOUHY.
• Code Information: REF: 332077; Product Code: CE17TBFC; UDI-DI (Primary): 4046964177187; UDI-DI (Unit of Use): 4046964177170; Lot Number: 0062022053. Expiration Date: 10/16/2024
• Recalling Firm/ Manufacturer: B BRAUN MEDICAL INC; 861 Marcon Blvd; Allentown PA 18109-9577
• For Additional Information Contact: Allison Longenhagen; 001-484-2408373
• Manufacturer Reason for Recall: Potential for the lid of the catheter connector to be in the incorrect position.
• FDA Determined Cause: Process control
• Action: B Braun notified consignees on about 09/18/2025 via USPS certified mailed URGENT MEDICAL DEVICE CORRECTION NOTIFICATION. Consignees were instructed to, where possible, have a second kit or additional catheter connector available at the point of use and upon opening the kit, verify the correct catheter connector is present. If the affected component is detected, discard and do not use. Consignees were also instructed to review the Medical Device Correction Notification and ensure all users in your organization and other concerned persons are informed, if affected units have been further distributed, notify customers, post the notification where affected units are stored, and complete and return the "Urgent Medical Device Correction Acknowledgement Form." Additionally, if consignees have identified affected units in inventory, they may order one case (50 pieces) of affected sterilized single use catheter connectors to have on hand.
• Quantity in Commerce: 0 units
• Distribution: Nationwide distribution 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.