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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 71mm - delivery system 16 FR; Catalog no. TFLE-24-71.
Model / Serial
Lots F1573048, F1571074, F1561902, F1569266, F1565685, F1569268, F1565686, F1565687, F1565689, F1573057, F1573058, F1573059, F1573060, F1573061, F1573049, F1573050, F1565688, F1571072, F1571073, F1571075, F1561419, F1573052, F1575274, F1575275, F1575365, F1575366, F1575367 and F1575368.
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 71mm - delivery system 16 FR; Catalog no. TFLE-24-71.
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 71mm - delivery system 16 FR; Catalog no. TFLE-24-71.
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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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