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Devices
Cook brand Zenith AAA Converter with the H&L-B; One-Shot Introducer System, preloaded converter - proximal diameter 24 mm - distal diameter 12 mm - length 80 mm; Reorder no. ESC-24-12-80.
Model / Serial
Lots 1356524, 1356532, 1356519, 1356525, 1356523, 1356522 and 1356529.
Product Classification
Cardiovascular Devices
Device Class
3
Implanted device?
Yes
Distribution
Nationwide, Canada, Denmark and Japan.
Product Description
Cook brand Zenith AAA Converter with the H&L-B; One-Shot Introducer System, preloaded converter - proximal diameter 24 mm - distal diameter 12 mm - length 80 mm; Reorder no. ESC-24-12-80.
Manufacturer
Cook, Inc.
1 Event
Recall of Cook brand Zenith AAA Converter with the H&L-B; One-Shot Introducer System, preloaded converter - proximal diameter 24 mm - distal diameter 12 mm - length 80 mm; Reorder no. ESC-24-12-80.
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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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