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 105mm - delivery system 14 FR; Catalog no. TFLE-12-105.

Model / Serial
Lots 1366558, 1366557, F1548671, F1548672, F1548673, F1552559, F1552558, F1552560, F1556413, F1558972, F1556414, F1556415, F1559009, F1561366, F1561367, F1559010, F1559011, F1564328, F1564329, F1564330, F1564331, F1564332, F1564138, F1564139, F1564140, F1564141, F1571027, F1564101, F1564102, F1565783, F1565784, F1565785, F1564333, F1564334, F1571028, F1571029, F1575220, F1575221, F1571558, F1572934, F1572936, F1572935, 1366554 and 1366555.
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 105mm - delivery system 14 FR; Catalog no. TFLE-12-105.
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 105mm - delivery system 14 FR; Catalog no. TFLE-12-105.

Manufacturer

Cook, Inc.

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

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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