Varian Segmented Cervix Applicator Set Recalled for Difficult Disconnection
Varian Medical Systems is recalling 15 units of the Segmented Cervix Applicator Set because the guide tube is difficult to disconnect from the cervical sleeve.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a mechanical difficulty (difficult disconnection) without reporting any injuries, illnesses, or fatalities, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Varian Medical Systems, Inc. is recalling 15 units of the Segmented Cervix Applicator Set, part number GM11004310. This medical device is a component used for Brachytherapy to treat cancer of the cervix, vagina, endometrium, vaginal stump, and uterus.
The recall was initiated because the guide tube, which is part of the set, is difficult to disconnect from the cervical sleeve. The affected units are identified by Lot L33 and specific serial numbers including H64Y009-GM, H64A056, H640576, H600272, H640784, H640774, H640764, H600603, and H640547.
The affected units were distributed worldwide, specifically in the U.S. state of Georgia and in Canada, Germany, India, Poland, and Thailand. Healthcare providers and patients should contact Varian Medical Systems for instructions on how to proceed with the recall.
The recalled product
- Product
- 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, v
- Manufacturer
- Varian Medical Systems, Inc.
- Hazard
- Affected units
- 15
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (10)
- Lot L33
- Serial numbers H64Y009-GM
- H64A056
- H640576
- H600272
- H640784
- H640774
- H640764
- H600603
- H640547
Distribution
Distributed in 1 state:
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