FDA Medical Device Recalls (openFDA)
Cardinal Health 303 Inc DBA Alaris Products: Texium Closed Male Luer (CML), Model Number 10012241, Cardinal Health, SanDiego, CA.
- Recall number
- Z-0218-2008
- Recalling firm
- Cardinal Health 303 Inc DBA Alaris Products
- Product
- Texium Closed Male Luer (CML), Model Number 10012241, Cardinal Health, SanDiego, CA.
- Status
- Terminated
- Initiated
- 2007-08-30
- Posted
- 2007-11-08
- Terminated
- 2012-03-28
- Reason
- Leaks: there is a risk of leakage at the female end of the Texium closed male luer (CML) when attached to a spin luer. (NOTE: users who connect the female portion of the Texium closed male luer to fixed (one-piece) male luers on tubing or on syringes are not affected by this issue)
- Root cause
- Finished device change control
- Action
- Recall notification was made via a Safety Alert Notification Letter dated August 30, 2007. Recall will be conducted through consignees (distributors) in the affected countries, as well as, direct customers for the Texium closed male luer. The customers and distributors will be notified by registered return receipt mail. For direct customers, separate letters will be sent to the Director of Nursing, Director of Materials and Director of Risk Management, and Director of Pharmacy at each facility. Distributors were sent multiple copies of the Safety Alert Notification and Tip Sheets; along with a cover letter outlining their responsibilities to complete the Safety Alert plan and notify their sub-account customers. The domestic letters (direct customers and distributors) were mailed on August 30, 2007 to all of the affected accounts. The international notifications will be coordinated out of the offices located in the affected countries. The appropriate international regulatory authorities will be notified of this issue, which will work with the country managers at each location.
- Quantity
- 76, 300 units
- Distribution
- Worldwide: USA including states of Arkansas, California, Colorado, Hawaii, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Maine, Michigan, Mississippi, North Carolina, New England, New Hampshire, New Jersey, New York, Ohio, Oregon, Pennsylvania, South Carolina, Texas, Utah, Virginia, Washington, and Wisconsin. and countries of Australia, Canada, Japan and Switzerland
- Lot, serial or model codes
- Model Number 10012241 (all lot numbers)
- 510(k) numbers
- ["K053049"]
- PMA numbers
- not on file
- Product code
- FPA
- Firm FEI
- 3003879246
- Firm city
- San Diego
- 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