PERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga. x 3-1/2 in. (8.9cm) Tuohy Epidural Needle - Winged and 19 Ga. Closed tip PERIFIX FX Springwound Epidural Catheter. Product Code: CE17TKFCPS. Product Description: CE17TKFCPS EPIDURAL FULL TRAY.
- Company
- B Braun Medical Inc
- Recall Initiated
- September 18, 2025
- Posted
- October 9, 2025
- Recall Number
- Z-0115-2026
- Quantity
- 0 units
- Firm Location
- Allentown, PA
Reason for Recall
Potential for the lid of the catheter connector to be in the incorrect position.
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.
Lot / Code Info
REF: 332078; Product Code: CE17TKFCPS; UDI-DI (Primary): 04046955899432; UDI-DI (Unit of Use): 04046955899449; Lot Numbers: 0062006314, 0062011670, 0062028428. Expiration Date: 07/31/2026
Root Cause
Process control
Action Taken
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.