CORDIS "Fire Star" 2.25 x 30 Dilatation Catheter, Catalog # 80130225, Distributed by Cordis Corporation, Miami Lakes, FL

FDA device recall Z-0819-2008 · posted 2008-02-06 · Terminated

Recall details

Recalling firm

Cordis Corporation

Reason for recall

Slow Deflation or No Deflation

Action taken

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.

Root cause

Process control

Status

Terminated

Product code

LOX

Quantity affected

133,300 units total for recalls Z-0747-0824-2008

Distribution

Worldwide.

Date initiated

2008-01-14

Date posted

2008-02-06

Date terminated

2009-10-20

Location

Miami Lakes, FL