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Devices
Cook brand Zenith Flex AAA Endovascular graft with the H&L-B; One-Shot Introduction System( A= 26mm, B=126mm, C=96mm, D=12mm, E= 18.0f, F=.035'', G =40cm); Reorder number TFBB-26-96.
Model / Serial
All units distributed on or before 12/17/04.
Product Classification
Cardiovascular Devices
Device Class
3
Implanted device?
Yes
Distribution
Nationwide and Canada.
Product Description
Cook brand Zenith Flex AAA Endovascular graft with the H&L-B; One-Shot Introduction System( A= 26mm, B=126mm, C=96mm, D=12mm, E= 18.0f, F=.035'', G =40cm); Reorder number TFBB-26-96.
Manufacturer
Cook, Inc.
1 Event
Recall of Cook brand Zenith Flex AAA Endovascular graft with the H&L-B; One-Shot Introduction System( A= 26mm, B=126mm, C=96mm, D=12mm, E= 18.0f, F=.035'', G =40cm); Reorder number TFBB-26-96.
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Manufacturer
Cook, Inc.
Manufacturer Address
Cook, Inc., 750 Daniels Way, Bloomington IN 47404-9120
Source
USFDA
Language
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