Flexible Implant tube, blind end, 350 mm, part # GM11003730, labeled in part ***Varian Medical Systems, Inc 3100 Hansen Way Palo Alto, CA 94304 USA www.varian.com***. Available as single unit or contained in the Flexible Interstitial Implant Tube Set, part number GM11004680. For use with the Varian GammaMed Plus brachytherapy afterloader device.
FDA Recall Z-0921-05 · Posted 2005-06-22
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Recalling FirmVarian Medical Systems
Recall StatusTerminated
Product CodeJAQ
Date Initiated2005-04-14
Date Terminated2005-08-22
Product Quantity33 devices in domestic distribution
Reason for Recall
A defective treatment applicator in a cancer therapy medical device may become separated potentially causing patient injury.
Firm Action
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
Distribution Pattern
Product was distributed to direct accounts in CT, MI, PA, CO, VT and MO. Product was additionally sold to foreign accounts in internationally.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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