VariSource AL13198000, Intralumenal Kit

FDA device recall Z-0820-06 · posted 2006-04-27 · Terminated

Recall details

Recalling firm

Alpha Omega Services Inc

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.

Action taken

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

Status

Terminated

Product code

JAQ

Quantity affected

17

Distribution

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

Date initiated

2006-02-21

Date posted

2006-04-27

Date terminated

2006-08-30

Location

Bellflower, CA