NeoMed Enteral Feeding Tubes with Enteral Only Connectors, French sizes 4.0Fr, 5.0Fr, 6.5Fr, 8.0Fr, and lengths 40cm, 60
FDA device recall Z-0093-2019 · posted 2018-10-10 · Terminated
Recall details
- Recalling firm
- Neomed Inc
- Reason for recall
- Potential for the tethered plug on the hub of the NeoMed Enteral Feeding Tubes with Enteral Only Connectors to inadvertently open after closure.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- FPD
- Quantity affected
- 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, Loui
- Date initiated
- 2018-06-04
- Date posted
- 2018-10-10
- Date terminated
- 2020-07-21
- Location
- Woodstock, GA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NEOMED POLYURETHANE FEEDING TUBE (K082238) | Neomed, Inc. | 2008-10-01 |