| Date Initiated by Firm | May 15, 2005 |
|---|
| Date Posted | June 16, 2005 |
|---|
| Recall Status1 |
Terminated 3 on September 16, 2005 |
| Recall Number | Z-0897-05 |
|---|
| Recall Event ID |
32092 |
| 510(K)Number | K932449 |
|---|
| Product Classification |
unknown device name - Product Code KOG
|
| Product | Dr. Fog Endoscopic fog prevention kit. |
|---|
| Code Information |
Lot 2007-05-25; exp. May 2007. |
| FEI Number |
3002750084
|
Recalling Firm/
Manufacturer |
Aspen Surgical Products, Inc.
7425 Clyde Park Ave Sw Ste G
Byron Center MI 49315-8373
|
| For Additional Information Contact |
888-364-7004 |
|---|
Manufacturer Reason
for Recall | An improper expiration date was placed on the individual packages, although the dispenser box and carton contained the correct expiration date. |
|---|
FDA Determined
Cause 2 | Process control |
|---|
| Action | Consignees were notified via phone on 5/15/05. Wholesalers were requested to notify their customers. |
|---|
| Quantity in Commerce | 2460 packages. |
|---|
| Distribution | Nationwide. |
|---|
|
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 = KOG
|
|---|
