Recall Z-0602-2016— Ethicon, Inc.
Class II · Terminated
Class II FDA medical device recall by Ethicon, Inc., initiated 2015-12-03, terminated 2017-05-30. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Stability data does not substantiate the labeled two-year shelf life of affected product..
- Recalling firm
- Ethicon, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-12-03
- Terminated
- 2017-05-30
- Firm location
- Somerville, NJ, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.