EBI VueCath Endoscopic Spinal System
FDA device recall Z-1006-03 · posted 2003-07-15 · Terminated
Recall details
- Recalling firm
- EBI, L.P.
- Reason for recall
- Non sterile device is labeled sterile.
- Action taken
- 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.
- Root cause
- Labeling False and Misleading
- Status
- Terminated
- Product code
- GWG
- Quantity affected
- 39
- Distribution
- Hospitals, clinics, and doctors nationwide.
- Date initiated
- 2003-06-17
- Date posted
- 2003-07-15
- Date terminated
- 2003-12-31
- Location
- Parsippany, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EBI TARGETCATH FLUORO-GUIDED STEERABLE CATHETER SYSTEM (K023233) | Ebi, L.P. | 2002-12-13 |
| EBI VUECATH SPINAL ENDOSCOPIC SYSTEM (K010179) | Ebi, L.P. | 2001-02-09 |
| EBI VUECATH ENDOSCOPIC SPINAL SYSTEM (K982484) | Electro-Biology, Inc. | 1998-10-08 |
| ARTHROSCOPE (K971083) | Electro-Biology, Inc. | 1997-06-23 |