Device Recall Profiler Balloon Catheter 의 리콜

Recall

59831

Class 2

Z-3262-2011

2011-02-25

2011-09-19

Terminated

United States

2012-10-18

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103830

The particular lots of profiler pta balloon catheters were labeled incorrectly. lot 532109 contains product that is actually 5 mm x 4 cm x 40 cm and lot 532794 contains product that is actually 4 mm x 2 cm x 40 cm.

Angiodynamics, Inc sent a "Urgent Medical Device Recall letter" dated February 25, 2011 to all affected customers via Certified Mail Return Receipt Requested. The letter identified the product the problem and the action needed to be taken by the customer. The customer was instructed the following steps 1. Identify and segregate the recalled lot that is in your possession. 2. Complete the enclosed Profiler PTA Balloon Catheter Recall Reply Form and fax it to the attention of the Profiler PTA Balloon Catheter Recall Coordinator at 518-798-1360. The form lists the catalog numbers, lot numbers, and quantity our records indicate your facility has received. For further questions please call 1-800-772-6446.