FDAFDA · Food and drugs·Recall number Z-0607-2013
Segmented Cervix Applicator Set, part number GM11004310, a component used with the tube for segments and cervical sleeves The guide tube for segments and cervical sleeves in the Segmented Cervix Applicator Set was developed to treat cancer of the cervix, vagina, endometrium, vaginal stump and uterus. It is used for Brachytherapy.
Published December 26, 2012 · Recall initiated: September 28, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The guide tube which is part of the Segmented Cervix Applicator Set is difficult to disconnect from cervical sleeve.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Varian Medical Systems, Inc.
- Distributor
- Worldwide Distribution - U.S. state of Georgia and the countries of Canada, Germany, India, Poland, and Thailand.
- Lot
- Lot L33, Serial numbers H64Y009-GM, H64A056, H640576, H600272, H640784, H640774, H640764, H600603, H640547,
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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