Recall Z-0093-2019 ยท FPD Tube, Feeding
Neomed Inc
NeoMed Enteral Feeding Tubes with Enteral Only Connectors, French sizes 4.0Fr, 5.0Fr, 6.5Fr, 8.0Fr, and lengths 40cm, 60cm, 90cm. The product consists of a polyurethane feeding tube with an attached hub and tethered plug to close the hub when the feeding tube is not in use. Product Usage: Intended for use in neonatal and pediatric patients to provide nutrition via nasal or oral gastric placement
| Date | Oct 10, 2018 (initiated Jun 4, 2018) |
| Status | Terminated |
| Reason | Potential for the tethered plug on the hub of the NeoMed Enteral Feeding Tubes with Enteral Only Connectors to inadvertently open after closure. |
| Root cause | Other |
| Action | On about 06/04/2018, NeoMed notified customers via "URGENT: MEDICAL DEVICE RECALL." Instructions included to examine inventory for affected devices, notify customers if the devices have been further distributed, complete and return the Response Form, and arrange for the return of all affected devices to NeoMed. Questions can be directed to NeoMed at 888-876-2225. |
| Quantity | 208,260 units (20,826 cases) |
| Distribution | Worldwide Distribution - US Nationwide in the states of: Alaska, Alabama, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082238 | NEOMED POLYURETHANE FEEDING TUBE Neomed, Inc., Oct 1, 2008 |