Z-0818-06

VariSource AL 13197000, Tongue/Soft Tissue Kit

Name: Z-0818-06 VariSource AL 13197000, Tongue/Soft Tissue Kit
Creator: Alpha Omega Services Inc
Published: 2006-02-21
License: https://open.fda.gov/license/

Alpha Omega Services Inc / initiated 2006-02-21 / Terminated

FDA source

Alpha Omega Services Inc began a recall of VariSource AL 13197000, Tongue/Soft Tissue Kit on 2006-02-21. The reason FDA records is "There is a possibility that the diameter of the catheter does not meet specifications. As a result it may not be possible to correctly connect the catheter to a VariSource Quick Connect. This would prevent any...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0818-06
Status: Terminated
Initiated: 2006-02-21
Posted: 2006-04-27
Terminated: 2006-08-30
Recalling firm: Alpha Omega Services Inc
Product: VariSource AL 13197000, Tongue/Soft Tissue Kit
Product code: JAQ System, Applicator, Radionuclide, Remote-Controlled
Reason for recall: There is a possibility that the diameter of the catheter does not meet specifications. As a result it may not be possible to correctly connect the catheter to a VariSource Quick Connect. This would prevent any treatment. Furthermore, since the problem would not be apparent until after the catheter has been implanted an unnecessary surgical implantation procedure would have taken place.
FDA root cause: Other
Action: Recall Notification Letter: began February 22, 2006. Depth/Scope: 100% of the customer''s who purchased the affected products will be identified and contacted with a faxed and mailed Medical Device Recall notice and followed up with a phone call by the AOS Sales & Marketing personnel. All customers will be requested return all affected products, both used and unused.
Quantity in commerce: 64
Distribution: Nationwide and Argentina, Brasil, Canada, Israel, Korea, , Taiwan, United Kingdom & Venezuela
Product codes and lots: All Lots

Product code JAQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)