Z-0921-05

Flexible Implant tube, blind end, 350 mm, part # GM11003730, labeled in part ***Varian Medical Systems, Inc...

Name: Z-0921-05 Flexible Implant tube, blind end, 350 mm, part # GM11003730, labeled in part ***Varian Medical Systems, Inc...
Creator: Varian Medical Systems
Published: 2005-04-14
License: https://open.fda.gov/license/

Varian Medical Systems, Inc. / initiated 2005-04-14 / Terminated

FDA source

Varian Medical Systems began a recall of Flexible Implant tube, blind end, 350 mm, part # GM11003730, labeled in part ***Varian Medical Systems, Inc 3100 Hansen Way Palo Alto, CA 94304 USA... on 2005-04-14. The reason FDA records is "A defective treatment applicator in a cancer therapy medical device may become separated potentially causing patient injury". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0921-05
Status: Terminated
Initiated: 2005-04-14
Posted: 2005-06-22
Terminated: 2005-08-22
Recalling firm: Varian Medical Systems, Inc.
Product: 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.
Product code: JAQ System, Applicator, Radionuclide, Remote-Controlled
Reason for recall: A defective treatment applicator in a cancer therapy medical device may become separated potentially causing patient injury.
FDA root cause: Other
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.
Quantity in commerce: 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.
Product codes and lots: Lot 04/21/1

Product code JAQ

K983436Class IIGammamed Plus High Dose Rate Remote Afterloading SystemGammamed USA / cleared 1998-10-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)