Recall Z-0441-06 ยท KNQ Dilator, Esophageal
Cook Endoscopy
SGD-12-70 Savary-Gilliard Dilator - Diameter: 12MM./36 FR. Length: 70 CM Reusable
| Date | Jan 25, 2006 (initiated Jan 5, 2006) |
| Status | Terminated |
| Reason | The dilator size does not match the label on the product and product packaging. |
| Root cause | Other |
| Action | 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. |
| Distribution | Canada and Australia |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K851955 | SAVARY-GILLIARD DILATOR Wilson-Cook Medical, Inc., Jul 25, 1985 |