Texium Closed Male Luer (CML), Model Number 10012241, Cardinal Health, SanDiego, CA.
FDA device recall Z-0218-2008 · posted 2007-11-08 · Terminated
Recall details
- Recalling firm
- Cardinal Health 303 Inc DBA Alaris Products
- 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)
- Action taken
- 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.
- Root cause
- Finished device change control
- Status
- Terminated
- Product code
- FPA
- Quantity affected
- 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 Hampshi
- Date initiated
- 2007-08-30
- Date posted
- 2007-11-08
- Date terminated
- 2012-03-28
- Location
- San Diego, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ALARIS SAFETY MALE LUER (K053049) | Cardinal Health, Alaris Products | 2006-01-12 |