Recalls / —
—#67885
Product
CORDIS "Fire Star" 2.25 x 15 Dilatation Catheter, Catalog # 80115225, Distributed by Cordis Corporation, Miami Lakes, FL 33014 .
- FDA product code
- LOX — Catheters, Transluminal Coronary Angioplasty, Percutaneous
- Device class
- Class 2
- Medical specialty
- Cardiovascular
- PMA numbers
- P880003
- Affected lot / code info
- Lot #s: 13203920 13214554 13216623 13222783 13224942 13242133 13255711 13264400 13268856 13281194 13281400 13281448 13296515 13306294 13310117 13320189 13324439 and 13329055
Why it was recalled
Slow Deflation or No Deflation
Root cause (FDA determination)
Process control
Action the firm took
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.
Recalling firm
- Firm
- Cordis Corporation
- Address
- 14201 NW 60th Avenue, Miami Lakes, Florida 33014-2802
Distribution
- Distribution pattern
- Worldwide.
Timeline
- Recall initiated
- 2008-01-14
- Posted by FDA
- 2008-02-06
- Terminated
- 2009-10-20
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #67885. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.