HSG Procedure Tray. Model Number: 6050T. The HSG Procedure Tray is for use in hysterosalpingography and sonohysterography procedures.
- Company
- Coopersurgical, Inc.
- Recall Initiated
- June 11, 2025
- Posted
- July 18, 2025
- Recall Number
- Z-2135-2025
- Quantity
- 171 units
- Firm Location
- Trumbull, CT
Reason for Recall
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.
Distribution
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.
Lot / Code Info
Model Number: 6050T. UDI-DI 60888937003262. Lot Numbers: 339331, 339327, 339333, 339334, 343007.
Root Cause
Under Investigation by firm
Action Taken
CooperSurgical notified consignees on about 06/11/2025 via letter sent through certified mail. Specifically, consignees that are physicians or medical facilities were instructed to identify and quarantine any affected product in inventory, complete and return the provided response form, and work with CooperSurgical to arrange for the return of affected units. Distributors were instructed to identify and quarantine any affected product in inventory, complete and return the provided response form, and work with CooperSurgical to arrange for the return of affected units. They were also instructed to notify customers if the product was further distributed.