Recall Z-3259-2011 ยท DQO Catheter, Intravascular, Diagnostic
Angiodynamics Worldwide Headquarters
ANGIODYNAMICS Angiographic Catheter, Soft-Vu Cobra (2) BRAIDED, 5 F x 90 cm x .035 in., Catalog No./REF 10709105, STERILE, MANUFACTURED IN USA, AngioDynamics, Inc. 603 Queensbury Avenue, Queensbury, NY 12804 Angiographic catheter
| Date | Sep 16, 2011 (initiated Jun 7, 2011) |
| Status | Terminated |
| Reason | The lot of Soft-Vu Catheters was labeled 90 cm in length; however the product was cut to a 65 cm length. |
| Root cause | Employee error |
| Action | The firm ANGIODYNAMICS, Inc., sent an "URGENT: MEDICAL DEVICE RECALL" letter dated June 7, 2011 to the consignees via Certified Mail, Return Receipt Requested. The letter described the product, problem and action to be taken. The customers were instructed not to use the product and to return it to AngioDynamics, Inc. in Queensbury, NY. The letter also instructed the consignees to (1.) Identify and segregate the recalled lot that is in your possession, (2.) Complete the enclosed Soft-Vu Angiographic Catheter Recall Reply Form and fax it to the attention of the Soft-Vu Angiographic Catheter R |
| Quantity | Domestic - 25 units; Foreign - 5 units |
| Distribution | Worldwide distribution: USA (nationwide) including states of: California, Tennessee, and Wisconsin, and country of: Spain. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K061733 | ANGIODYNAMICS SOFT-VU AND MARINER HYDROPHILIC COATED ANGIOGRAPHIC CATHETER AngioDynamics, Inc., Aug 24, 2006 |