Recall Z-1853-2017 ยท FPA Set, Administration, Intravascular
Angiodynamics Inc. (Navilyst Medical Inc.)
NAMIC Fluid Delivery Set - 72" (183cm) UPN H965913000051, Catalog 91300005
| Date | Mar 29, 2017 (initiated Jan 13, 2017) |
| Status | Terminated |
| Reason | The product has the potential to be non-sterile as it was not packaged in accordance to specification. |
| Root cause | Under Investigation by firm |
| Action | On January 13, 2017 Navilyst Medical initiated a recall action by contacting the 6 consignees by telephone and directing them to stop using the affected product and segregate until receipt of written Recall Notification. Recall Notifications dated January 19, 2017 were delivered by Federal Express to these consignees on January 20, 2017. Per the Recall Notification, Consignees are instructed to segregate and return all affected devices to Navilyst Medical, Inc. (an AngioDynamics Company) and complete and return the Reply Verification Tracking Form, provided in the recall notification. |
| Quantity | 8 boxes/25 units |
| Distribution | CA, KY, MD, OR, VA, TX |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K852140 | NAMIC CONTRAST & FLUID DELIVERY SPIKES(VARIOUS) North American Instrument Corp., May 30, 1985 |