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U.S. Department of Health and Human Services

Class 2 Device Recall Texium Closed Male Luer (CML),

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 Class 2 Recall
Texium Closed Male Luer (CML),
see related information
Date Posted November 08, 2007
Recall Status1 Open
Recall Number Z-0218-2008
Recall Event ID 44826
Premarket Notification
510(K) Number
K053049 
Product Classification Set, Administration, Intravascular - Product Code FPA
Product Texium Closed Male Luer (CML), Model Number 10012241, Cardinal Health, SanDiego, CA.
Code Information Model Number 10012241 (all lot numbers)
Recalling Firm/
Manufacturer
Cardinal Health 303 Inc DBA Alaris Products
10221 Wateridge Cir
San Diego, California 92121-2733
For Additional Information Contact Stacy L. Lewis
858-458-7563
Manufacturer 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 Determined
Cause 2
CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): 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
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FPA and Original Applicant = CARDINAL HEALTH, ALARIS PRODUCTS
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