Gynecare Thermachoice III

Indicated to remove the endometrial lining of the uterus in premenopausal women with menorrhagia (excessive hemorrhage) due to benign causes and who have completed the gestational phase.

Model: TC033, Affected: All unexpired lots

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TC003 (US Only) TC013 (US Only) TC033 (OUS Only) TC043 (OUS Only).   Code, Batch: TC04320, GMMG07; TC00320, GMMG08; TC00320, GMMG09; TC00320, GMMG10; TC04320, GMMG11; TC03320, GPMG01; TC04320, GPMG02; TC00320, GPMG03; TC00320, GPMG04; TC00320, GPMG05; TC01320, GPMG06; TC04320, GPMG07; TC03320, GPMG08; TC04320, GPMG09; TC00320, GPMG10; TC00320, GPMG11; TC00320, HAMG01; TC00320, HAMG02; TC03320, HAMG03; TC04320, HAMG04; TC00320, HAMG05; TC00320, HAMG06; TC00320, HAMG07; TC00320, HAMG08; TC01320, HAMG09; TC03320, HAMG10; TC04320, HAMG11; TC04320, HAMG12; TC00320, HAMG13; TC00320, HAMG14; TC00320, HBMG01; TC00320, HBMG02; TC04320, HBMG03; TC04320, HBMG04; TC03320, HBMG05; TC00320, HBMG06; TC00320, HBMG07; TC04320, HBMG08; TC03320, HBMG09; TC00320, HBMG10; TC00320, HCMG01; TC00320, HCMG02; TC00320, HCMG03; TC00320, HCMG04; TC04320, HCMG05; TC04320, HCMG06; TC03320, HDMG01; TC00320, HDMG02; TC00320, HDMG03; TC00320, HDMG04; TC00320, HDMG05; TC03320, HEMG01; TC04320, HEMG02; TC01320, HEMG03; TC00320, HEMG05; TC00320, HEMG06; TC00320, HEMG07; TC00320, HEMG08; TC04320, HEMG09; TC04320, HGMG01; TC03320, HGMG02; TC00320, HGMG03; TC00320, HGMG04; TC00320, HGMG05; TC00320, HGMG06; TC00320, HGMG07; TC04320, HGMG08; TC04320, HGMG09; TC04320, HGMG10; TC00320, HHMG01; TC00320, HHMG02; TC00320, HHMG03; TC00320, HHMG04; TC03320, HHMG05; TC04320, HHMG06; TC00320, HHMG08; TC00320, HHMG09; TC00320, HHMG10; TC04320, HHMG07; TC00320, HHMG11; TC00320, HHMG12; TC00320, HJMG02; TC00320, HJMG03; TC00320, HJMG04; TC00320, HJMG05; TC00320, HJMG06; TC01320, HJMG07; TC03320, HJMG08; TC04320, HJMG09; TC04320, HJMG10; TC00320, HJMG11; TC00320, HJMG12; TC00320, HJMG13; TC04320, HKMG01; TC00320, HJMG14; TC04320, HKMG02; TC03320, HKMG03; TC00320, HKMG04; TC00320, HKMG05; TC00320, HKMG06; TC04320, HKMG07; TC03320, HKMG08; TC00320, HKMG10; TC00320, HKMG09; TC00320, HKMG11; TC00320, HLMG01; TC00320, HLMG02; TC00320, HLMG03; TC01320, HLMG04; TC04320, HLMG05; TC03320, HLMG06; TC00320, HLMG07; TC00320, HLMG08; TC00320, HLMG09; TC04320, HLMG10; TC03320, HMMG01; TC04320, HMMG02; TC00320, HMMG03; TC00320, HMMG04; TC04320, HMMG05; TC00320, HMMG06; TC00320, HMMG07; TC00320, HPMG01; TC00320, HPMG02; TC04320, HPMG04; TC03320, HPMG03; TC04320, HPMG05; TC00320, HPMG06; TC00320, HPMG07; TC00320, JAMG01; TC00320, JAMG02; TC04320, JAMG03; TC00320, JAMG05; TC00320, JAMG04; TC01320, JAMG06; TC00320, JAMG07; TC04320, JAMG08; TC00320, JAMG10; TC03320, JAMG09; TC00320, JAMG11; TC00320, JBMG01; TC04320, JBMG02; TC04320, JBMG03; TC03320, JBMG04; TC00320, JBMG05; TC00320, JBMG06; TC00320, JBMG07; TC04320, JBMG08; TC00320, JBMG09; TC00320, JBMG10; TC00320, JBMG11; TC04320, JCMG01; TC03320, JCMG02; TC00320, JCMG03; TC00320, JCMG04; TC01320, JCMG05; TC04320, JDMG01; TC00320, JDMG02; TC00320, JDMG03; TC00320, JDMG04; TC04320, JDMG05; TC00320, JDMG06; TC04320, JDMG07; TC00320, JEMG01; TC00320, JEMG02; TC00320, JEMG03; TC00320, JEMG04; TC03320, JEMG05; TC00320, JGMG02; TC04320, JGMG03; TC03320, JGMG04; TC00320, JGMG05; TC00320, JGMG09; TC04320, JGMG10; TC04313, JGMG14; TC04320, JGMG15; TC00320, JGMG16; TC03320, JGMG17; TC00320, JGMG18; TC00320, JHMG02; TC04320, JHMG05; TC00320, JHMG03; TC04320, JHMG04; TC00320, JHMG06; TC00320, JHMG07; TC00320, JHMG08; TC00320, JHMG09; TC00320, JHMG10; TC04320, JHMG11; TC00320, JHMG12; TC03320, JJMG01; TC00320, JJMG02; TC00320, JJMG04; TC00320, JJMG05; TC01320, JJMG06; TC00320, JJMG07; TC03313, JJMG08; TC00320, JJMG09; TC04313, JKMG02; TC00320, JKMG01; TC03313, JKMG03; TC00320, JKMG04; TC00320, JKMG05; TC00320, JKMG06; TC00320, JKMG08; TC04313, JLMG01; TC00320, JLMG02; TC00320, JLMG04; TC03313, JLMG05; and TC00320, JLMG06. As of 1/8/2016, 5 Additional lots (US Only - JKMG01, JKMG04 and JKMG05; OUS Only - JKMG02 and JKMG03) were found to be affected by this field action.

Obstetrical and Gynecological Devices

2

No

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

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.

Injections / Infusions / Transfusions / Dialysis - catheters