Recall Z-0828-03 ยท GCJ Laparoscope, General & Plastic Surgery
Aspen Surgical Products, Inc.
Dr. Fog Endoscopic Fog Prevention Kit; model DF-3120. Each box contains 40 packages. Each package contains one Dr. Fog treated sponge.
| Date | May 15, 2003 (initiated Apr 30, 2003) |
| Status | Terminated |
| Reason | Sterility compromised - incomplete sterile package seal. |
| Root cause | 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. |
| Quantity | 299 boxes |
| Distribution | Nationwide, Japan and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K932449 | DR. FOG O.R. Concepts, Inc., Aug 11, 1993 |