FDA Medical Device Recalls (openFDA)
Alpha Omega Services Inc: VariSource AL 13199024, Implant Tube, Implant Tube, Intralumenal(HDR), 10CM Drawdown 130CM Body, Sealed End, Cable Insert & Gold Seed, Disposable
- Recall number
- Z-0816-06
- Recalling firm
- Alpha Omega Services Inc
- Product
- VariSource AL 13199024, Implant Tube, Implant Tube, Intralumenal(HDR), 10CM Drawdown 130CM Body, Sealed End, Cable Insert & Gold Seed, Disposable
- Status
- Terminated
- Initiated
- 2006-02-21
- Posted
- 2006-04-27
- Terminated
- 2006-08-30
- 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
- 24
- Distribution
- Nationwide and Argentina, Brasil, Canada, Israel, Korea, , Taiwan, United Kingdom & Venezuela
- Lot, serial or model codes
- All Lots
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JAQ
- Firm FEI
- 2022694
- Firm city
- Bellflower
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28