Device Recall Dura Star 의 리콜

Recall

46378

Class 1

Z-0764-2008

2008-01-14

2008-02-06

Terminated

United States

2009-10-20

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=67367

Slow deflation or no deflation.

Cordis initated the recall on 1/14/2008. For U.S. customers: An Urgent Medical Device Recall letter and an Acknowledgement Form was sent to the following 4 individuals in each account: Cath Lab Director, Operating Room Director, Materials Director, Risk Manager; to be followed up with direct Cordis representative contact to facilitate obtaining signature, faxing form, collecting and returning units. For non-US customers, email notification with return acknowledgement is used to notify the affiliate distributors, who then notify and reconcile the customers in those countries. All users were instructed to immediately set aside product and return it for replacement.