Device product
Combined Spinal and Epidural Anesthesia Tray 2, PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle, PENCAN 27 Ga. x 5 in. (12.7 cm) Spinal Needle, and 19 Ga. Closed Tip PERIFIX FX Springwound Epidural Catheter. Product Code: SESK. Product Description: SESK COMBINED SPINAL AND EPIDURAL TRAY 2.
Z-0125-2026
Product summary
- Event
- Event 97550
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 60 units
- Official record key
device-enforcement:Z-0125-2026
Official wording
Reason: Potential for the lid of the catheter connector to be in the incorrect position.
Code information: REF: 530185; Product Code: SESK; UDI-DI (Primary): 04046955625147; UDI-DI (Unit of Use): 04046955625130; Lot Number: 0062003227. 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.