Devices

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 71mm - delivery system 14 FR; Catalog no. TFLE-12-71.

Model / Serial
Lots 1359093, 1359087, 1359095, 1359096, 1365218, 1362945, 1362958, 1362946, 1362954, 1365215, 1359089, 1362957, 1362959, 1359085, F1559029, F1559031, F1559032, F1559033, F1559030, F1564220, F1564221, F1564222, F1564223, F1564342, F1564154, F1564218, F1564219, F1565728, F1565729, F1565730, F1565731, F1565732, F1569301, F1571566, F1571567, F1569302, F1572948, F1572949, F1571568, F1571569, F1571570, F1578364, F1576373, F1576374, F1576375, F1576377, 1359088, 1362955, 1362960, 1359083, 1362961, 1359084, 1359082, 1359091, 1359090, 1359086 and 1359097.
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 71mm - delivery system 14 FR; Catalog no. TFLE-12-71.
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 12 mm - usable length 71mm - delivery system 14 FR; Catalog no. TFLE-12-71.

Manufacturer

Cook, Inc.

Manufacturer Address
Cook, Inc., 750 Daniels Way, Bloomington IN 47404-9120
Source
USFDA

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