Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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

FDA Recall Z-0794-2007 · Posted 2007-05-10

Recalling FirmBoston Scientific
Recall StatusTerminated
Product CodeDTK
Date Initiated2006-10-06
Date Terminated2012-07-03
Product Quantity24 units

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.

Firm 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.

Root Cause

Other

Distribution Pattern

Nationwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K964284STAINLESS STEEL GREENFIELD VENA CAVA FILTER WITH 12F INTRODUCER SYSTEMBoston Scientific Corp · 1997-01-06

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑