CooperSurgical, Inc. recalls HSG Procedure Tray. Model Number: 6050T. The HSG Procedu
See all recalls from CooperSurgical, Inc. →Recalled Product
HSG Procedure Tray. Model Number: 6050T. The HSG Procedure Tray is for use in hysterosalpingography and sonohysterography procedures.
Hazard / Issue
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.
Issued by
FDA
Distribution: Nationwide (United States)
Lot/Code Info: Model Number: 6050T. UDI-DI 60888937003262. Lot Numbers: 339331, 339327, 339333, 339334, 343007.
✅ What Should You Do?
- 1Contact your healthcare provider immediately to discuss this recall.
- 2Stop using the device if it is safe to do so, and contact your provider.
- 3Follow the manufacturer's remedy instructions provided in the recall notice.
- 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.
Looking for a safe alternative?
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