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Manufacturers
Cook Urological, Inc.
Manufacturer Address
Cook Urological, Inc., 1100 W Morgan St, Spencer IN 47460-9426
Source
USFDA
4 Events
Recall of Device Recall Cook PTFE Wire Guide
Recall of fascial dilator
Recall of Device Recall Cook Flexor DL
Recall of Device Recall Cook Harrison fetal bladder stent
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4 devices in the database
Device Recall Cook PTFE Wire Guide
Model / Serial
Lot U1621121
Product Classification
Gastroenterology-Urology Devices
Device Class
1
Implanted device?
No
Distribution
Nationwide and Canada.
Product Description
Cook PTFE Wire Guide with 3 cm flexible tip, to establish a tract for ureteral/renal access, .038", 145 cm; sterile; Order/Ref number 638413.
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.
Device Recall Cook Flexor DL
Model / Serial
Lot U1546391.
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
No
Distribution
Massachusetts, Maine, New Hampshire and Puerto Rico.
Product Description
Cook Flexor DL Dual Lumen Ureteral Access Sheath with AQ Coating, sterile, REF FUS-095013-DL.
Device Recall Cook Harrison fetal bladder stent
Model / Serial
All units.
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
Yes
Distribution
Nationwide, Australia, Canada, Caracas, Chile, Colombia, Hong Kong, India, Ireland, Israel, Malaysia, Mexico, New Zealand, Paraguay, Taiwan and Venezuela.
Product Description
Cook Harrison fetal bladder stent set, sterile; REF J-HFBS-503540.
One manufacturer with a similar name
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Cook Urological, Inc.
Manufacturer Address
Cook Urological, Inc., 1100 West Morgan, Spencer IN 47460
Source
USFDA
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