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Cook brand Zenith AAA Iliac leg graft with the H&L-B; One-Shot Introducer System, preloaded iliac leg graft - distal cuff diameter 12 mm - usable length 54mm - delivery system 14 FR; Catalog no. TFLE-12-54.
Model / Serial
Lots 1359073, 1359079, 1359064, 1359076, F1550328, F1550329, F1550330, F1549761, F1552568, F1552569, F1552570, F1552571, F1554548, F1556419, F1556420, F1554547, F1555390, F1556418, F1556421, F1556422, F1559022, F1559023, F1559024, F1559025, F1559026, F1564339, F1564144, F1564145, F1564146, F1564147, F1564148, F1564149, F1564150, F1564136, F1561373, F1561374, F1561375, F1561376, F1564337, F1564338, F1564340, F1564341, F1565723, F1565724, F1565725, F1565726, F1565727, F1565786, F1565787, F1565788, F1565789, F1565790, 1359080, 1359074, 1354034, 1359067, 1363354, 1357534, 1357533 and 1359081.
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 12 mm - usable length 54mm - delivery system 14 FR; Catalog no. TFLE-12-54.
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 12 mm - usable length 54mm - delivery system 14 FR; Catalog no. TFLE-12-54.
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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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