Recall Z-0794-2007 ยท DTK Filter, Intravascular, Cardiovascular
Boston Scientific
Boston Scientific Medi-Tech Stainless Steel Greenfield Vena Cava Filter, order #50-400, lot #7826572
| Date | May 10, 2007 (initiated Oct 6, 2006) |
| Status | Terminated |
| Reason | One lot of product, Stainless Steel Greenfield Vena Cava Filter, may have the incorrect expiration date of 2008-07 and the correct date is 2008-06. |
| Root cause | Other |
| Action | Consignees were notified by letter (10/06/2006) which was accompanied by a Reply Verification Letter. All consignees were asked to cease use of product upon receipt of the letter and to fax the Reply Verification Letter to recalling firm and return product to firm. |
| Quantity | 24 units |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K964284 | STAINLESS STEEL GREENFIELD VENA CAVA FILTER WITH 12F INTRODUCER SYSTEM Boston Scientific Corp, Jan 6, 1997 |