Device product
PERIFIX FX Continuous Epidural Anesthesia Tray with 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: CE17TKFC. Product Description: CE17TKFC EPIDURAL TRAY W/ 17GA TUOHY.
Z-0116-2026
Product summary
- Event
- Event 97550
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 48,110 units
- Official record key
device-enforcement:Z-0116-2026
Official wording
Reason: Potential for the lid of the catheter connector to be in the incorrect position.
Code information: REF: 332079; Product Code: CE17TKFC; UDI-DI (Primary): 04046955899456; UDI-DI (Unit of Use): 04046955899463; Lot Numbers: 0062010541, 0062010542, 0062010543, 0062010545, 0062010546, 0062010547, 0062010548, 0062010549, 0062010550, 0062010743, 0062013041, 0062013042, 0062013043, 0062013044, 0062013045, 0062013046, 0062013047, 0062013049, 0062015114, 0062015113, 0062015112, 0062015110. 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.