Varian Medical Recalls Breast Template System Due to Sterilization Defect
Varian Medical Systems is recalling 3 sets of the VARISOURCE Breast Template System because the templates may bend and turn opaque after steam sterilization.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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, but the source text does not report any hospitalizations, injuries, or illnesses. The hazard is a functional defect (bending/opacification) rather than a direct biological or physical injury risk, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Varian Medical Systems, Inc. is recalling 3 sets of the VARISOURCE Breast Template System for high-dose rate Brachytherapy. The affected lots are #6078184-1, #6078184-2, and #6078184-4. The product was distributed worldwide, including nationwide in the United States (specifically California) and in India.
The recall was initiated after Varian Medical became aware that the Lexan templates of the Breast Bridge Template System could become bent and turn opaque after steam sterilization. This defect may affect the functionality of the device during medical procedures.
Healthcare facilities and users of the affected product should stop using the recalled templates and contact Varian Medical Systems for further instructions on how to return or dispose of the product.
The recalled product
- Product
- VARISOURCE Breast Template System for high-dose rate Brachytherapy. ***INSTRUCTIONS FOR USE*** Breast Bridge & Template System AL13011000 ***Manufacturer: Varian Medical Systems, Inc., 3100 Hansen Way, Palo Alto, CA 94304 USA
- Manufacturer
- Varian Medical Systems, Inc.
- Affected units
- 3
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 (3)
- Lots #6078184-1
- #6078184-2
- #6078184-4
Distribution
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