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U.S. Department of Health and Human Services

Class 2 Device Recall AlphaOmega Services, Inc. TII0002

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 Class 2 Device Recall AlphaOmega Services, Inc. TII0002see related information
Date Initiated by FirmFebruary 21, 2006
Date PostedApril 27, 2006
Recall Status1 Terminated 3 on August 30, 2006
Recall NumberZ-0813-06
Recall Event ID 34969
Product Classification System, Applicator, Radionuclide, Remote-Controlled - Product Code JAQ
ProductTII0002 Implant Tube, Implant Tube, Intralumenal(HDR), 10CM Drawdown 130CM Body, Sealed End, Cable Insert & Gold Seed, Disposable
Code Information All Lots
FEI Number 2022694
Recalling Firm/
Manufacturer		 Alpha Omega Services Inc
9156 Rose St
Bellflower CA 90706
For Additional Information ContactBob A. Robnett
562-804-0604
Manufacturer 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 Determined
Cause 2		Other
ActionRecall 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 Commerce260
DistributionNationwide and Argentina, Brasil, Canada, Israel, Korea, , Taiwan, United Kingdom & Venezuela
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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