Recalls / —
—#67893
Product
CORDIS "Fire Star" 3.50 x 15 Dilatation Catheter, Catalog # 80115350, 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: 13211700 13216622 13251135 13271985 13274542 13281195 13281226 13281311 13281368 13281438 13282050 13284572 13287300 13287302 13291129 13306317 13307101 and 13321815
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 #67893. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.