Recall Z-0777-2017 ยท DYB Introducer, Catheter
Angiodynamics, Inc.
ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 5 F Stiffened Micro-Introducer Kit, 45CM NT/T NON-ECHO B PG, Item Number H787065970685, Catalog No.REF 06597068, 2) 1) 5 F Stiffened Micro-Introducer Kit, 45CM NT/T NON-ECHO S PG, Item Number H787065970705, Catalog No.REF 06597070 Indicated for percutaneous introduction of guidewire or catheter into the vascular system follow
| Date | Sep 28, 2016 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Component design/selection |
| Action | 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 AngioDyna |
| Quantity | 7 boxes |
| Distribution | Nationwide Distribution to AL, AR, CA, FL, GA, IL, KY, LA, MI, MN, MO, NC, OH, OK, SC, NY, ME, PA, MD, VA, WA, WI, WV, TN, and TX |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051655 | ANGIODYNAMICS, INC., MICRO ACCESS KITS AngioDynamics, Inc., Sep 12, 2005 |