Atlas FDA

Boston Scientific Medi-Tech Stainless Steel Greenfield Vena Cava Filter, order #50-400, lot #7826572

FDA device recall Z-0794-2007 · posted 2007-05-10 · Terminated

Recall details

Recalling firm
Boston Scientific
Reason for recall
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.
Action taken
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.
Root cause
Other
Status
Terminated
Product code
DTK
Quantity affected
24 units
Distribution
Nationwide.
Date initiated
2006-10-06
Date posted
2007-05-10
Date terminated
2012-07-03
Location
Maple Grove, MN

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Related 510(k) clearances

RecordFirmDate
STAINLESS STEEL GREENFIELD VENA CAVA FILTER WITH 12F INTRODUCER SYSTEM (K964284)Boston Scientific Corp1997-01-06