Z-0218-2008

Texium Closed Male Luer (CML), Model Number 10012241, Cardinal Health, SanDiego, CA

Name: Z-0218-2008 Texium Closed Male Luer (CML), Model Number 10012241, Cardinal Health, SanDiego, CA
Creator: Cardinal Health 303 Inc DBA Alaris Products
Published: 2007-08-30
License: https://open.fda.gov/license/

CareFusion 303, Inc / initiated 2007-08-30 / Terminated

FDA source

Cardinal Health 303 Inc DBA Alaris Products began a recall of Texium Closed Male Luer (CML), Model Number 10012241, Cardinal Health, SanDiego, CA on 2007-08-30. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0218-2008
Status: Terminated
Initiated: 2007-08-30
Posted: 2007-11-08
Terminated: 2012-03-28
Recalling firm: CareFusion 303, Inc
Product: Texium Closed Male Luer (CML), Model Number 10012241, Cardinal Health, SanDiego, CA.
Product code: FPA Set, Administration, Intravascular
Reason for recall: 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)
FDA 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 in commerce: 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
Product codes and lots: Model Number 10012241 (all lot numbers)

Product code FPA

K053049Class IIAlaris Safety Male LuerCardinal Health, Alaris Products / cleared 2006-01-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)