FDA Recall Terminated

ANGIODYNAMICS PROFILER BALLOON DILATATION CATHETER, Catalog No./REF 16801101, BALLOON DIAMETER 4MM, BALLOON LENGTH 2 CM, CATHETER LENGTH 40 CM, STERILE, MANUFACTURED IN USA AngioDynamics 603 Queensbury Avenue, Queensbury, NY 12804 Cardiovascular catheterization

Recall: Z-3261-2011 · Initiated February 25, 2011

Recall

Recall Number: Z-3261-2011
Event Number: 59831
Firm: Angiodynamics Worldwide Headquarters
FEI Number: 3008319439
Product Code: DQY
Status: Terminated
Root Cause: Employee error
Initiated: February 25, 2011
Posted: September 19, 2011
Terminated: October 18, 2012
Address: 14 Plaza Drive, Latham, NY, 12110-3421

Description

Reason

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.

Action

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.

Distribution

Nationwide Distribution including the states of CA, GA, ID, MI, OH and PA.

Quantity

15 units