Device Recall MassTRANSIT Infusion Catheter Kit 의 리콜

Recall

50154

Class 2

Z-0604-2009

2008-06-30

2008-12-30

Terminated

United States

2009-01-02

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=74869

Two lots of cordis neurovascular masstransit infusion catheter kits has the potential for sterile ptfe contamination within the inner lumen of the catheter.

A Medical Device Recall letter, dated 6/30/2008, and Acknowledgement Form were sent overnight. The firm asked customers to set aside any affected product in a manner that ensures it will not be used. Customers are asked to review, sign and return the enclosed Acknowledgement Form directly to Cordis Neurovascular. Customers can either return any product with reference to the RA# on the form, or contact their local sales reps to facilitate return of the affected product. Customers will receive a credit for the units they return. If any affected product has been forwarded to another facility, the facility should be contacted to arrange return of the product. If there are any additional questions, Customer Service may be also be contacted at 800-551-7683.