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Devices
HemaCarotid Patch, Ultrathin, Collagen Coated Knitted Polyester Vascular Patch. || Product Catalog Numbers: || HEK06/75CPUT; || HEK08/75CPUT; || HEK14/75CPUT; || HEK08/120CPUT; || HEK10/75CPUT; || HEK25/100CPUT; || HEK12/75CPUT; || HEK10/150CPUT.
Model / Serial
Lot Numbers: 03G03; 03H08; 03J25; 03G10; 03H28; 03K02; 03G17; 03J04; 03K09; 03G24; 03J11; 03K16; 03G31; 03J18; 03K23.
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
Yes
Distribution
The product has been shipped nationwide to 53 hospitals, 4 government hospitals, and 3 sales representatives.
Product Description
HemaCarotid Patch, Ultrathin, Collagen Coated Knitted Polyester Vascular Patch. || Product Catalog Numbers: || HEK06/75CPUT; || HEK08/75CPUT; || HEK14/75CPUT; || HEK08/120CPUT; || HEK10/75CPUT; || HEK25/100CPUT; || HEK12/75CPUT; || HEK10/150CPUT.
Manufacturer
Datascope Corporation
1 Event
Recall of HemaCarotid Patch, Ultrathin, Collagen Coated Knitted Polyester Vascular Patch. || Product Catalog Numbers: || HEK06/75CPUT; || HEK08/75CPUT; || HEK14/75CPUT; || HEK08/120CPUT; || HEK10/75CPUT; || HEK25/100CPUT; || HEK12/75CPUT; || HEK10/150CPUT.
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Manufacturer
Datascope Corporation
Manufacturer Address
Datascope Corporation, 14 Philips Pkwy, Montvale NJ 07645-1811
Source
USFDA
Language
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