SGD-12-70 Savary-Gilliard Dilator - Diameter: 12MM./36 FR. Length: 70 CM Reusable
FDA device recall Z-0441-06 · posted 2006-01-25 · Terminated
Recall details
- Recalling firm
- Cook Endoscopy
- Reason for recall
- The dilator size does not match the label on the product and product packaging.
- Action taken
- A recall letter was issued to the consignees on 1/5/06 requesting return of the product. The letter also requested a sub-recall if the product had been further distributed.
- Root cause
- Other
- Status
- Terminated
- Product code
- KNQ
- Distribution
- Canada and Australia
- Date initiated
- 2006-01-05
- Date posted
- 2006-01-25
- Date terminated
- 2006-04-04
- Location
- Winston Salem, NC
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SAVARY-GILLIARD DILATOR (K851955) | Wilson-Cook Medical, Inc. | 1985-07-25 |