Z-0119-2026 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- October 15, 2025
- Initiation Date
- September 18, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 21,270 units
Product Description
PERIFIX FX Continuous Epidural Anesthesia Tray, PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle - Winged and 19 Ga. Closed tip PERIFIX FX Springwound Epidural Catheter. Product Code: CE17TKFCS. Product Description: CE17TKFCS CONT EPID TRAY W/17G TUOHY-LF.
Reason for Recall
Potential for the lid of the catheter connector to be in the incorrect position.
Distribution Pattern
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.
Code Information
REF: 332097; Product Code: CE17TKFCS; UDI-DI (Primary): 04046955899470; UDI-DI (Unit of Use): 04046955899487; Lot Numbers: 0062013051, 0062010532, 0062010533, 0062010534, 0062010535, 0062010536, 0062010555, 0062013050, 0062013053, 0062013052. Expiration Date: 07/31/2026.