Device product
PERIFIX FX Continuous Epidural Anesthesia Tray, 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle - Fixed Wings, 19 Ga. Open tip PERIFIX FX Springwound Epidural Catheter. Product Code: CE17TKFSDT. Product Description: CE17TKFSDT EPID TRAY W/17GA FIXED WING.
Z-0118-2026
Product summary
- Event
- Event 97550
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 0 units
- Official record key
device-enforcement:Z-0118-2026
Official wording
Reason: Potential for the lid of the catheter connector to be in the incorrect position.
Code information: REF: 332093; Product Code: CE17TKFSDT; UDI-DI (Primary): 04046964954252; UDI-DI (Unit of Use): 04046964954245; Lot Number: 0062003112. Expiration Date: 07/31/2026.
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.
Derived failure modes
-
Unknown
Potential for the lid of the catheter connector to be in the incorrect position.