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.
Reported: January 13, 2016 Initiated: December 3, 2015 #Z-0602-2016
Product Description
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.
Reason for Recall
Stability data does not substantiate the labeled two-year shelf life of affected product.
Details
- Recalling Firm
- Ethicon, Inc.
- Units Affected
- 96,124 units
- Distribution
- Worldwide Distribution: US (nationwide) including Puerto Rico and countries of: India, Belgium, Argentina, Mexico, Brazil, Canada, Colombia, Ecuador, Singapore, Aruba and Venezuela.
- Location
- Somerville, NJ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Ethicon, Inc.. Units affected: 96,124 units.
Why was this product recalled? ▼
Stability data does not substantiate the labeled two-year shelf life of affected product.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 13, 2016. Severity: Moderate. Recall number: Z-0602-2016.
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