Device 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.
Z-0114-2026
Product summary
- Event
- Event 97550
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 0 units
- Official record key
device-enforcement:Z-0114-2026
Official wording
Reason: Potential for the lid of the catheter connector to be in the incorrect position.
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
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.