| Date Initiated by Firm | January 05, 2006 |
|---|
| Date Posted | January 25, 2006 |
|---|
| Recall Status1 |
Terminated 3 on April 04, 2006 |
| Recall Number | Z-0441-06 |
|---|
| Recall Event ID |
34326 |
| 510(K)Number | K851955 |
|---|
| Product Classification |
Dilator, Esophageal - Product Code KNQ
|
| Product | SGD-12-70 Savary-Gilliard Dilator - Diameter: 12MM./36 FR. Length: 70 CM Reusable |
|---|
| Code Information |
Lot W2048624 |
| FEI Number |
1037905
|
Recalling Firm/
Manufacturer |
Cook Endoscopy
5951 Grassy Creek Blvd
Winston Salem NC 27105-1206
|
| For Additional Information Contact | Sharon Miles
336-744-0157 Ext. 6325 |
|---|
Manufacturer Reason
for Recall | The dilator size does not match the label on the product and product packaging. |
|---|
FDA Determined
Cause 2 | Other |
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| 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 |
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| Total Product Life Cycle | TPLC Device Report |
|---|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
| 510(K) Database | 510(K)s with Product Code = KNQ
|
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