Recall Z-1435-06 ยท FSO Microscope, Surgical, General & Plastic Surgery
Microvision Medical Holding B.V.
MicroScan Lens Disposable Plastic Cap used with MicroScan Video Microscope, MicroVisionMedical brand
| Date | Aug 23, 2006 (initiated Jul 21, 2006) |
| Status | Terminated |
| Reason | Some lenses may have microscopic holes in the disposable caps representing a potential break in the sterile barrier |
| Root cause | Other |
| Action | The recalling firm issued a recall letter dated 7/21/06 to their customers informing them of the problem and the need to return the product. |
| Quantity | 540 caps |
| Distribution | World wide-The product was shipped to physicians in UT, IA, OR, MA, LA, CA. The product was also shipped to Germany, United Kingdom, and The Netherlands. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.