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Devices
Cook brand Zenith AAA Iliac leg graft with the H&L-B; One-Shot Introducer System, preloaded iliac leg graft - distal cuff diameter 24 mm - usable length 37mm - delivery system 16 FR; Catalog no. TFLE-24-37.
Model / Serial
Lots F1571587, F1565752, F1569263, F1569264, F1569265, F1565751, F1575271 and F1575272.
Product Classification
Cardiovascular Devices
Device Class
3
Implanted device?
Yes
Distribution
Nationwide, Canada, Denmark and Japan.
Product Description
Cook brand Zenith AAA Iliac leg graft with the H&L-B; One-Shot Introducer System, preloaded iliac leg graft - distal cuff diameter 24 mm - usable length 37mm - delivery system 16 FR; Catalog no. TFLE-24-37.
Manufacturer
Cook, Inc.
1 Event
Recall of Cook brand Zenith AAA Iliac leg graft with the H&L-B; One-Shot Introducer System, preloaded iliac leg graft - distal cuff diameter 24 mm - usable length 37mm - delivery system 16 FR; Catalog no. TFLE-24-37.
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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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