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.
Hazard
One unit of Hemashield Finesse Ultra-thin Knitted Cardiovascular Patch which did not meet the internal release criteria for water permeability was distributed.
What You Should Do
Remedy
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.
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Products
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,
- Brand
- Maquet Cardiovascular, LLC
- UPC
- 510 k - K962342, Product Code/UP #M00202019579P0; Batch #25018564; Exp Date 7/31/2005
Units Affected
one unit