Retiro De Equipo (Recall) de Device Recall Cordis Radial Source Spring Wire Transradial Access Kit Product

Recall

65464

Class 2

Z-1608-2013

2013-05-31

2013-06-27

Terminated

United States

2014-08-04

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118983

Cordis corporation, inc and greatbatch medical are recalling one lot of the cordis radialsource spring wire transradial access kit product. some units were manufactured with an undersized vessel dilator tip, too small to slide over the guidewire.

Greatbatch Medical and Cordis sent an "Urgent Field Safety Notice" dated May 31, 2012, to all affected customers. The letter identified the product the problem and the action to be taken by the customer. Customers were instructed: 1.Read the Description of the problem section. 2. Immediately identify and set aside all product listed above in a manner that ensures the affected product will not be used. 3. Review, complete, sign and return the enclosed Acknowledgement Form in accordance with the directions on the form. 4. Either return any affected product per the attached instruction, or contact your local sales representative to facilitate return of the affected product. Credit will be provided. 5. Pass on this notice to anyone in your facility that needs to be informed. 6. If any product listed above has been forwarded to another facility, contact that facility to arrange return. 7. Maintain awareness of this notice until all product listed above has been removed from the facility and returned to Cordis. 8. Maintain a copy of this notice with affected product until product is returned. We apologize for any inconvenience this communication may cause. We know that you place high value in our products and we appreciate your cooperation in this matter. Cordis and Greatbatch are committed to maintaining your confidence in the safety and quality of the products that Greatbatch manufactures and Cordis supplies. Further questions please call (763) 951-8181.