Recall Z-0775-2017

Reason for recall

Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined that the products listed in their September 7, 2016 Recall Notification have the potential for the rotating luer to detach from the dilator hub during use. AngioDynamics has confirmed that affected sheath/dilators (Greatbatch Model Numbers 10904-001 and 10904-002) have been included in packaged AngioDynamics Stiffened Micro-Introducer Kits.

FDA-determined cause: Component design/selection

Action taken

Angiiodynamics sent an Urgent Voluntary Medical Device Recall letter dated September 28, 2016, to all affected customers. Recall notifications were delivered by Federal Express. Customers were instructed to segregate and return all affected devices to AngioDynamics and to complete and return the Reply Verification Tracking Form, provided in the recall notification by fax to 1-800-782-1357. Customers were encouraged to forward a copy of the recall notification to all sites to which have distributed affected product. If affected product is located in your institution, please call AngioDynamics Customer Service at 1-800-772-6446 between 8:00 a.m. and 7:00 p.m. (Monday Friday: Eastern Standard Time) to obtain a replacement or credit for your returned product. Promptly complete, sign and return the enclosed Reply Verification Tracking Form (even if you do not have any product to return); following the directions on this page and the Reply Verification Tracking Form via to recall@angiodynamics.com. Customers with questions should contact customer service at 1-800-772-6446.