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Device Recall Hemashield Finesse UltraThin Knitted Cardiovascular Patch
Model / Serial
510 k - K962342, Product Code/UP #M00202019579P0; Batch #25018564; Exp Date 7/31/2005
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
Yes
Distribution
Nationwide distribution: SC only.
Product Description
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.
Manufacturer
Maquet Cardiovascular, LLC
1 Event
Recall of Device Recall Hemashield Finesse UltraThin Knitted Cardiovascular Patch
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Manufacturer
Maquet Cardiovascular, LLC
Manufacturer Address
Maquet Cardiovascular, LLC, 45 Barbour Pond Dr, Wayne NJ 07470-2094
Manufacturer Parent Company (2017)
Getinge AB
Source
USFDA
One device with a similar name
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Device Recall Hemashield Finesse Ultrathin Knitted Cardiovascular Patch.
Model / Serial
xxx
Product Classification
Cardiovascular Devices
Device Class
3
Implanted device?
Yes
Distribution
Nationwide Distribution.
Product Description
Hemashield Finesse Ultra-thin Knitted Cardiovascular Patch.
Manufacturer
Maquet Cardiovascular, LLC
Language
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