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Devices
Device Recall CVI (Cardiovascular Innovations)
Model / Serial
Lot Numbers: XX-02-X; XXX-03-X; XXX-04-X; XXX-05-X; 356-05; 356-06; 360-06; 361-06; 024-07; 044-07; 045-07; 046-07, where X is any number.
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide, including USA, Canada, Netherlands, and Germany.
Product Description
CVI OZ Palm Injector, used to perfuse contrast media into vessels for angiographic procedures. Ref : OZ 1035 (Cardiovascular Innovations LLC)
Manufacturer
Lemaitre Vascular, Inc.
1 Event
Recall of Device Recall CVI (Cardiovascular Innovations)
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Manufacturer
Lemaitre Vascular, Inc.
Manufacturer Address
Lemaitre Vascular, Inc., 63 Second Avenue, Burlington MA 01803-4413
Source
USFDA
Language
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