Device Recall UNIFUSE INFUSION SYSTEM 의 리콜

Recall

59820

Class 2

Z-3267-2011

2011-01-28

2011-09-19

Terminated

United States

2012-10-18

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103807

The particular lots of unifuse catheters were packaged with the wrong occluding ball guidewires.

URGENT MEDICAL DEVICE RECALL LETTERS (dated 1/28/11) and Recall Reply Forms were sent to the consignees via Certified Mail, Return Receipt Requested. The letters identified the scope of the recall, the reason for the recall, the status, and action to be taken. Customers were to identify and segregate the recalled lot in their possession. They were also to complete and fax back the Reply Form. The recalled product should be returned along with a copy of the Reply Form. Replacement product would be shipped upon receipt and confirmation of the returned product. Questions or concerns should be directed towards customers' local sales representative or call Julie Blair, Customer Service Manager at 1-800-772-6446.