| Class 2 Device Recall Texium Closed Male Luer (CML), | |
Date Initiated by Firm | August 30, 2007 |
Date Posted | November 08, 2007 |
Recall Status1 |
Terminated 3 on March 28, 2012 |
Recall Number | Z-0218-2008 |
Recall Event ID |
44826 |
510(K)Number | K053049 |
Product Classification |
Closed Male Luer - Product Code FPA
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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 CA 92121-2733
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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)
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FDA Determined Cause 2 | 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 |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = FPA
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