Device product
ESPOCAN Combined Spinal and Epidural Anesthesia Tray, ESPOCAN 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle, PENCAN 25 Ga. x 5 in. (12.7 cm) Spinal Needle with Marking and Centering Sleeve, and 19 Ga. Closed Tip PERIFIX FX Springwound Epidural Catheter. Product Code: ES1725KFX. Product Description: ES1725KFX ESPOCAN SPINAL/EPID. TRAY.
Z-0122-2026
Product summary
- Event
- Event 97550
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 10,130 units
- Official record key
device-enforcement:Z-0122-2026
Official wording
Reason: Potential for the lid of the catheter connector to be in the incorrect position.
Code information: REF: 333196; Product Code: ES1725KFX; UDI-DI (Primary): 04046955899531; UDI-DI (Unit of Use): 04046955899548; Lot Numbers: 0062005817, 0062011662, 0062011663, 0062014354, 0062011664. 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.