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Manufacturers
Datascope Interventional Products Division
Manufacturer Address
Datascope Interventional Products Division, 1300 Macarthur Blvd, Mahwah NJ 07430
Source
USFDA
1 Event
Recall of ProLumen Rotational Thrombectomy System. Catalog No. 86311, sold as a single unit packaged in a shelf carton.
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One device in the database
ProLumen Rotational Thrombectomy System. Catalog No. 86311, sold as a single unit packaged in a s...
Model / Serial
Lot Numbers--Exp.Date: M354580 -- 2004-03; M357300-- 2004-05; M401160-- 2004-08; M401170 -- 2004-08; M413790 --2004-09; M414240 -- 2004-09; M437260 -- 2004-10.
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
The product was shipped nationwide to 243 direct accounts. and to 7 government accounts.
Product Description
ProLumen Rotational Thrombectomy System. Catalog No. 86311, sold as a single unit packaged in a shelf carton.
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