Hemashield Finesse Ultra-Thin Knitted Cardiovascular Patch Indicated for cardiac and vascular patch grafting. The fabric is recommended for use in patients requiring systemic heparinization prior to, or during, surgery.
FDA Recall Z-1593-2011 · Posted 2011-03-07
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Recalling FirmMaquet Cardiovascular, LLC
Recall StatusTerminated
Product CodeDSY
Date Initiated2010-12-07
Date Terminated2012-09-12
Product Quantityone unit
Reason for Recall
One unit of Hemashield Finesse Ultra-thin Knitted Cardiovascular Patch which did not meet the internal release criteria for water permeability was distributed.
Firm Action
The firm, Maquet, contacted their sole consignee/customer via telephone informing the customer of the recall and instructing the customer to put the unit to the side. On December 8, 2010 a sales representative visited the site to ensure the unit had been put to the side and to ensure the unit was shipped back to Maquet.
If you have any questions, call the Manager, Regulator Affairs at 973-709-7487.
Root Cause
Other
Distribution Pattern
Nationwide distribution: SC only.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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