ANGIODYNAMICS PROFILER BALLOON DILATATION CATHETER, Catalog No./REF 16801105, BALLOON DIAMETER 5MM, BALLOON LENGTH 4 CM,

FDA device recall Z-3262-2011 · posted 2011-09-19 · Terminated

Recall details

Recalling firm

Angiodynamics Worldwide Headquarters

Reason for recall

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 taken

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.

Root cause

Employee error

Status

Terminated

Product code

DQY

Quantity affected

14 units

Distribution

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

Date initiated

2011-02-25

Date posted

2011-09-19

Date terminated

2012-10-18

Location

Latham, NY

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