Recall Z-0813-06 ยท JAQ System, Applicator, Radionuclide, Remote-Controlled
Alpha Omega Services Inc
TII0002 Implant Tube, Implant Tube, Intralumenal(HDR), 10CM Drawdown 130CM Body, Sealed End, Cable Insert & Gold Seed, Disposable
| Date | Apr 27, 2006 (initiated Feb 21, 2006) |
| Status | Terminated |
| Reason | 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. |
| 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 | 260 |
| Distribution | Nationwide and Argentina, Brasil, Canada, Israel, Korea, , Taiwan, United Kingdom & Venezuela |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.