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Devices
Device Recall High Permeability Hemodialysis System
Model / Serial
Serial numbers: PA0101 to PA0681.
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide.
Product Description
Gambro Prismaflex Hemodialysis Machine, Catalogue Number 6023014700, Gambro Dasco S.p.A, Italy.
Manufacturer
Gambro Renal Products, Inc.
1 Event
Recall of Device Recall High Permeability Hemodialysis System
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Manufacturer
Gambro Renal Products, Inc.
Manufacturer Address
Gambro Renal Products, Inc., 10810 W Collins Ave, Lakewood CO 80215-4439
Source
USFDA
Language
English
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