Recall Z-3261-2011 ยท DQY Catheter, Percutaneous
Angiodynamics Worldwide Headquarters
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
| Date | Sep 19, 2011 (initiated Feb 25, 2011) |
| Status | Terminated |
| 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. |
| Root cause | Employee error |
| 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 |
| Quantity | 15 units |
| Distribution | Nationwide Distribution including the states of CA, GA, ID, MI, OH and PA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K062609 | MODIFICATION TO ANGIODYNAMICS PROFILER PTA BALLOON CATHETER AngioDynamics, Inc., Oct 6, 2006 |