Flexible Implant tube, blind end, 350 mm, part # GM11003730, labeled in part ***Varian Medical Systems, Inc 3100 Hansen
FDA device recall Z-0921-05 · posted 2005-06-22 · Terminated
Recall details
- Recalling firm
- Varian Medical Systems
- Reason for recall
- A defective treatment applicator in a cancer therapy medical device may become separated potentially causing patient injury.
- Action taken
- The recalling firm notified end users by Customer Technical Bulletin on 4/14/05. The bulletin advised of potential for the blind end of the implant tube to become separated with the possible effect of the tube end being inhaled by a patient. Consignees were instructed to stop using product and return for replacement. The firm''s bulletin is also available on the company website.
- Root cause
- Other
- Status
- Terminated
- Product code
- JAQ
- Quantity affected
- 33 devices in domestic distribution
- Distribution
- Product was distributed to direct accounts in CT, MI, PA, CO, VT and MO. Product was additionally sold to foreign accounts in internationally.
- Date initiated
- 2005-04-14
- Date posted
- 2005-06-22
- Date terminated
- 2005-08-22
- Location
- Charlottesville, VA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GAMMAMED PLUS HIGH DOSE RATE REMOTE AFTERLOADING SYSTEM (K983436) | Gammamed USA | 1998-10-29 |