Recall Z-0218-2008 ยท FPA Set, Administration, Intravascular
Cardinal Health 303 Inc DBA Alaris Products
Texium Closed Male Luer (CML), Model Number 10012241, Cardinal Health, SanDiego, CA.
| Date | Nov 8, 2007 (initiated Aug 30, 2007) |
| Status | Terminated |
| 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 |
| 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, Washing |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K053049 | ALARIS SAFETY MALE LUER Cardinal Health, Alaris Products, Jan 12, 2006 |