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Manufacturers
Gambro Renal Products, Incorporated
Manufacturer Address
Gambro Renal Products, Incorporated, 14143 Denver West Pkwy, Lakewood CO 80401-3266
Manufacturer Parent Company (2017)
Baxter International
Source
USFDA
19 Events
Recall of Device Recall Prismaflex
Recall of Device Recall Gambro
Recall of Device Recall Gambro
Recall of Device Recall Gambro
Recall of Device Recall Gambro
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Recall of Device Recall Gambro
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Recall of Device Recall Gambro
Recall of Device Recall Gambro Cartridge Blood Set
Recall of Polyflux Revaclear Max, Capillary Dialyzer
Recall of Polyflux Revaclear, Capillary Dialyzer
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19 devices in the database
Device Recall Prismaflex
Model / Serial
All units with Version 3.20 software.
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide distribution.
Product Description
Prismaflex System, Catalog Number 107493, || Indicated for continuous solute and/or fluid removal in patients with acute renal failure or fluid overload.
Device Recall Gambro
Model / Serial
Model Number MARS Treatment Kit Type 1116/1 X-MARS US, Batch Number 0000020229, Expiry Date 02/2017
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution.
Product Description
X-MARS Set (component of MARS Treatment Kit Type 1116/1 X-MARS US), Product Number 800541
Device Recall Gambro
Model / Serial
Model Number MARS Treatment Kit Type 1115/1 PrisMARS US, Batch 0000017412 - 0000019827, Expiry Date 06/2014 to 05/2016
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution.
Product Description
PrisMARS Kit (component of MARS Treatment Kit Type 1115/1 PrisMARS US), 1 MARS Treatment Kit per carton box, Product Number 800480, Batch
Device Recall Gambro
Model / Serial
Prismaflex HF 1400. Product number 107142. Batch number 12A1005 to 14C1106. Expiry 01/2014 to 03/2016
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution.
Product Description
Prismaflex HF 1400. Product number 107142. Each set is packaged in a plastic pouch, 4 pouches per carton box
Device Recall Gambro
Model / Serial
Prismaflex HF 1000. Product number 107140. Batch number 12A0504 to 14C3105. Expiry 01/2014 to 03/2016
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution.
Product Description
Prismaflex HF 1000. Product number 107140. Each set is packaged in a plastic pouch, 4 pouches per carton box
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Gambro Renal Products, Incorporated
Manufacturer Parent Company (2017)
Baxter International
Source
RLMPH
Language
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