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Devices
fascial dilator
Model / Serial
Lots 15-U1320351 and 15-U1320349.
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
No
Distribution
California and Florida.
Product Description
Cook brand Fascial Dilator; 10FR/37cm, sterile, Rx Only, Cook Ireland Ltd., Limerick, Ireland; REF G14191; Catalog No. 073710.
Manufacturer
Cook Urological, Inc.
1 Event
Recall of fascial dilator
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Manufacturer
Cook Urological, Inc.
Manufacturer Address
Cook Urological, Inc., 1100 W Morgan St, Spencer IN 47460-9426
Source
USFDA
Language
English
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