Recall Z-0701-2007 ยท KDC Instrument, Surgical, Disposable
Scanlan International Inc
SCANLAN International Mobin-Uddin Vein Holder, Sterile, Disposable, single-use, catalog #1001-761, Lot AZ115806.
| Date | Apr 3, 2007 (initiated Feb 19, 2007) |
| Status | Terminated |
| Reason | Incorrectly assembled by manufacturer |
| Root cause | Other |
| Action | The consignees were notified of the product recall by letter dated February 19, 2007. Consignees were asked to return product to the manufacturer and replacement product is being offered. |
| Quantity | 35 units domestically ( 70 units to OUS) |
| Distribution | Worldwide distribution --- USA including states of IN, MO and country of Japan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.