Rectal Retractors, stainless steel, item # AL07289000, a component of Varian Medical Ring and Tandem Applicator Sets; In
FDA device recall Z-0759-2013 · posted 2013-01-31 · Terminated
Recall details
- Recalling firm
- Varian Medical Systems, Inc.
- Reason for recall
- A medical device used in brachytherapy may become contaminated and can cause infections, toxicity or allergic reactions.
- Action taken
- Varian Medical Systems an an Urgent Medical Device Correction letters dated April 11, 2012 and May 8, 2012 to all affected customers. The April notification advised of an anomaly with titanium rectal retractors, and the correction was expanded in May to include stainless steel retractors. In both notifications, users were instructed to discontinue use and quarantine their cleaned and sterilized devices for collection by Varian field service engineers. Users were requested to return an enclosed reply form to respond with number of units in inventory.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- JAQ
- Quantity affected
- 344 pieces
- Distribution
- US Nationwide Distribution
- Date initiated
- 2012-04-12
- Date posted
- 2013-01-31
- Date terminated
- 2014-04-10
- Location
- Charlottesville, VA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR (K011657) | Mick Radio-Nuclear Instruments, Inc. | 2001-08-27 |