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Device Recall Perouse Flamingo Angiographic injector/syringe
Model / Serial
Model 0218TA and 0218TB. Manufacturing Lot Numbers: 12031275 and 12031242. EXP.: 02/2017. Batches: 12031526, 12031249, 12031527, 12031248, 12041183, 12041186, 12031244, 12031461, 12031460, 12021404, 12031462, 12031245, 12021405, 12031405, 12031246, 12021401, 12041344, 12031237, 12031241, 12021403, 12041345, 12041184, 12031497, 12031240, 12021194, 12031524, 12031480, 12041181, 12031275, 12031242, 12021450, 12021449, 12041185, 12031525, 12031247, 12021402, 12021448.
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
US.
Product Description
Perouse Flamingo, Model 0218TA and 0218TB intended for use during cardiovascular procedure to create, maintain and monitor pressure in the balloon catheter.
Manufacturer
Perouse Medical
1 Event
Recall of Device Recall Perouse Flamingo Angiographic injector/syringe
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Manufacturer
Perouse Medical
Manufacturer Address
Perouse Medical, 135, Route Neuve, Irigny France
Manufacturer Parent Company (2017)
Perouse Medical
Source
USFDA
Language
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