Events

Recall of Device Recall Gynecare Thermachoice III

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ethicon, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    72840
  • Event Risk Class
    Class 2
  • Event Number
    Z-0602-2016
  • Event Initiated Date
    2015-12-03
  • Event Date Posted
    2016-01-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-05-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142341
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Catheter, balloon, dilation of cervical canal - Product Code PFJ
  • Reason
    Stability data does not substantiate the labeled two-year shelf life of affected product.
  • Action
    Ethicon, Inc. sent "Urgent: Medical Device Recall (REMOVAL)" notifications and Business Reply Forms dated 12/3/2015 on same date via UPS Next Day Mail to its customers. The notification informed the customers of the issue with the product; how to identify affected product and action required. The customers were instructed to examine their inventory immediately to determine if they have affected product on hand and quarantine the affected product(s); remove the affected product and communicate the issue to relevant operating room or materials management personnel, or anyone else in their facility who needs to be informed; if any affected product has been forwarded to another facility, contact that facility to arrange return; complete and return the enclosed Business Reply Form (BRF) confirming receipt of this notice within three (3) business days to Stericycle by fax at 1-866-792-5453 or by email at Ethicon7427@stericycle.com, return BRF even if you do not have affected product. Stericycle is handling returns. If the customer requires any assistance with returning product or have any questions, they were instructed to contact the Customer Support Center at 1-877-ETHICON (1-877-384-4266). Ethicon, Inc. issued an update to their 12/3/2015 letter in a notification dated 12/23/2015. The 12/23/2015 notification clarified the lots of the product subject to their recall previously communicated in their 12/3/2015 letter. There are three (3) lots of product subject to the recall that were inadvertently omitted from the original lot listing. The notification stated that "All THERMACHOICE¿ Catheter lots with an expiration date prior to December 10, 2017 are subject to this recall and are required to be returned. The lot number listing of all product subject to the recall is contained in Attachment 1. The expiration date and lot number can be determined by using the Product Identification Tool attached hereto at Attachment 2." The attachments included the updated pr

Device

Device Recall Gynecare Thermachoice III
  • Model / Serial
    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.
  • Product Classification
    Obstetrical and Gynecological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) including Puerto Rico and countries of: India, Belgium, Argentina, Mexico, Brazil, Canada, Colombia, Ecuador, Singapore, Aruba and Venezuela.
  • 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.
  • Manufacturer
    Ethicon, Inc.

Manufacturer

Ethicon, Inc.
  • Manufacturer Address
    Ethicon, Inc., US Highway 22 West, Somerville NJ 08876
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA