Device product
HSG Procedure Tray. Model Number: 6050T. The HSG Procedure Tray is for use in hysterosalpingography and sonohysterography procedures.
Z-2135-2025
Product summary
- Event
- Event 97028
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 171 units
- Official record key
device-enforcement:Z-2135-2025
Official wording
Reason: The HSG Procedure Trays and Endosee System Convenience Kits contain non-sterile iodine pouches, however the peel away lid labels incorrectly identify the iodine pouches as sterile.
Code information: Model Number: 6050T. UDI-DI 60888937003262. Lot Numbers: 339331, 339327, 339333, 339334, 343007.
Distribution pattern: US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and Washington DC.
Derived failure modes
-
Unknown
The HSG Procedure Trays and Endosee System Convenience Kits contain non-sterile iodine pouches, however the peel away lid labels incorrectly identify the iodine pouches as sterile.