Device product
Rectal Retractors, titanium, item # AL07368000, a component of Varian Medical Ring and Tandem Applicator Sets; Intended for use in Brachytherapy.
Z-0760-2013
Product summary
- Event
- Event 61879
- Status
- Terminated
- Classification
- Class II
- Quantity
- 152 units
- Official record key
device-enforcement:Z-0760-2013
Official wording
Reason: A medical device used in brachytherapy may become contaminated and can cause infections, toxicity or allergic reactions.
Code information: All lots
Distribution pattern: US Nationwide Distribution
Derived failure modes
-
Unknown
A medical device used in brachytherapy may become contaminated and can cause infections, toxicity or allergic reactions.