Device Recall Texium Closed Male Luer (CML), 의 리콜

Recall

44826

Class 2

Z-0218-2008

2007-08-30

2007-11-08

Terminated

United States

2012-03-28

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=64417

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).

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.