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Terminated

TIT0001-003, Implant Tube, Tongue/Soft Tissue, Puthawala/Syed:28cm Leader, 85cm Body, 15cm Draw-Down, Cable Insert, & Nylon Retaining Buttons

FDA Recall Z-0815-06 · Posted 2006-04-27

Recalling FirmAlpha Omega Services Inc
Recall StatusTerminated
Product CodeJAQ
Date Initiated2006-02-21
Date Terminated2006-08-30
Product Quantity1163

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.

Firm 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.

Root Cause

Other

Distribution Pattern

Nationwide and Argentina, Brasil, Canada, Israel, Korea, , Taiwan, United Kingdom & Venezuela

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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