Reported Jan 13, 2016 · Terminated
Gynecare Thermachoice III Uterine Balloon Therapy System Ethicon, Inc. The GYNECARE THERMACHOICE¿ III Uterine Balloon…
Ethicon, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ethicon, Inc. · US Highway 22 West · Somerville, NJ · 08876
Is this the product you have?
- 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.
- Lot codes and dates
211 of 211 products
Products covered by this recall # Product as published 1 TC04320, GMMG07 2 TC00320, GMMG08 3 TC00320, GMMG09 4 TC00320, GMMG10 5 TC04320, GMMG11 6 TC03320, GPMG01 7 TC04320, GPMG02 8 TC00320, GPMG03 9 TC00320, GPMG04 10 TC00320, GPMG05 11 TC01320, GPMG06 12 TC04320, GPMG07 13 TC03320, GPMG08 14 TC04320, GPMG09 15 TC00320, GPMG10 16 TC00320, GPMG11 17 TC00320, HAMG01 18 TC00320, HAMG02 19 TC03320, HAMG03 20 TC04320, HAMG04 - Amount recalled
- 96,124 units
Where it was sold
- Nationwide
- PR
Why it was recalled
Stability data does not substantiate the labeled two-year shelf life of affected product.
This product could cause temporary or reversible health problems — stop using it.
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