Dr. Fog Endoscopic Fog Prevention Kit; model DF-3120. Each box contains 40 packages. Each package contains one Dr. Fog t
FDA device recall Z-0828-03 · posted 2003-05-15 · Terminated
Recall details
- Recalling firm
- Aspen Surgical Products, Inc.
- Reason for recall
- Sterility compromised - incomplete sterile package seal.
- Action taken
- 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.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- GCJ
- Quantity affected
- 299 boxes
- Distribution
- Nationwide, Japan and United Kingdom.
- Date initiated
- 2003-04-30
- Date posted
- 2003-05-15
- Date terminated
- 2003-11-13
- Location
- Byron Center, MI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DR. FOG (K932449) | O.R. Concepts, Inc. | 1993-08-11 |