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Ethicon, Inc. recalls Gynecare Thermachoice III Uterine Balloon Therapy System Ethicon, Inc. The GYNECARE THERMACHOICE¿ III Uterine Balloon
Recalled January 13, 2016 · FDA recall Z-0602-2016 · Ethicon
Hazard
Stability data does not substantiate the labeled two-year shelf life of affected product. · FDA Class II
Units
96,124 units
Sold at
Worldwide Distribution: US (nationwide) including Puerto Rico and countries of: India, Belgium, Argentina, Mexico, Brazil, Canada, Colombia, Ecuador, Singapore, Aruba and Venezuela.
Description
Stability data does not substantiate the labeled two-year shelf life of affected product.
Product
Gynecare Thermachoice III Uterine Balloon Therapy System Ethicon, Inc. The GYNECARE THERMACHOICE¿ III Uterine Balloon Therapy (UBT) System is a thermal balloon ablation device intended to ablate the endometrial lining of the uterus in pre-menopausal women with menorrhagia (excessive uterine bleeding) due to benign causes for whom childbearing is complete.
Manufacturer(s)
Ethicon, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →