| Date Initiated by Firm | April 30, 2003 |
|---|
| Date Posted | May 15, 2003 |
|---|
| Recall Status1 |
Terminated 3 on November 13, 2003 |
| Recall Number | Z-0828-03 |
|---|
| Recall Event ID |
26188 |
| 510(K)Number | K932449 |
|---|
| Product Classification |
Laparoscope, General & Plastic Surgery - Product Code GCJ
|
| Product | Dr. Fog Endoscopic Fog Prevention Kit; model DF-3120. Each box contains 40 packages. Each package contains one Dr. Fog treated sponge. |
|---|
| Code Information |
Lot 2005-02-17. Exp. February 2005. |
| FEI Number |
3002750084
|
Recalling Firm/
Manufacturer |
Aspen Surgical Products, Inc.
7425 Clyde Park SW, Ste. G
Byron Center MI 49315
|
| For Additional Information Contact |
616-583-9280 |
|---|
Manufacturer Reason
for Recall | Sterility compromised - incomplete sterile package seal. |
|---|
FDA Determined
Cause 2 | Packaging process control |
|---|
| Action | The firm called each customer on 4/30/03 and requested that the product be returned. Distributors were asked to notify their customers of the recall. |
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| Quantity in Commerce | 299 boxes |
|---|
| Distribution | Nationwide, Japan and United Kingdom. |
|---|
| 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 = GCJ
|
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