Recall Z-1006-03 ยท GWG Endoscope, Neurological
EBI, L.P.
EBI VueCath Endoscopic Spinal System
| Date | Jul 15, 2003 (initiated Jun 17, 2003) |
| Status | Terminated |
| Reason | Non sterile device is labeled sterile. |
| Root cause | Labeling False and Misleading |
| Action | The firm notified their customers via a field correction letter dated June 17, 2003. Instructions given are to sterilize the unit prior to use. A EBI field representative will be visiting to replace the boxes. |
| Quantity | 39 |
| Distribution | Hospitals, clinics, and doctors nationwide. |
| FDA record | Open on fda.gov |