Gynecare Thermachoice III Uterine Balloon Therapy System Ethicon recalled over fire hazard

Recall date

December 3, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Ethicon, Inc. recalls Gynecare Thermachoice III Uterine Balloon Therapy System Ethicon, Inc. The GYNECARE THERMACHOICE¿ III Uterine Balloon T…

Recall number

Z-0602-2016

FDA classification

Class II

Brand / firm

Ethicon, Inc.

Sold / distributed

Worldwide Distribution: US (nationwide) including Puerto Rico and countries of: India, Belgium, Argentina, Mexico, Brazil, Canada, Colombia, Ecuador, Singapore, Aruba and Venezuela.

Why it was recalled

Stability data does not substantiate the labeled two-year shelf life of affected product.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What 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.