FDA-Device2025-07-30Class II
Endosee System Convenience Kit. Model Number: ES-TRAY. Endosee System Convenience Kit
CooperSurgical, Inc.
Hazard
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.
Sold states
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.
Affected count
991 units
Manufactured in
95 Corporate Dr, N/A, Trumbull, CT, United States
Products
Endosee System Convenience Kit. Model Number: ES-TRAY. Endosee System Convenience Kit
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2136-2025Don't want to check this manually?
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