Devices

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.
Manufacturer
Gambro Renal Products, Incorporated
1 Event
- Recall of Device Recall Prismaflex

Manufacturer

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

One device with a similar name

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Device Recall Prismaflex Control Unit

Model / Serial
Product code: 6023014700, 107493, 113081, 115269; Serial Number: All; Affected Software Versions: SW 4.1x, 5.10, 6.10, 7.xx, 8.00
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Algeria, Armenia, Australia, Bahrain, Belarus, Belgium, Canada, China, Cyprus, Denmark, Egypt, France, Germany, Great Britain, Greece, Ireland, Italy, Albania, Bulgaria, Croatia, Czech Republic, Estonia, Hong Kong, Hungary, Iceland, India, Iran, Israel, Ivory Coast, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Montenegro, Morocco, Netherlands, New Zealand, Nigeria, Norway, Pakistan, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sudan, Sweden, Switzerland, Syria, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, Ukraine, Vietnam, Yemen, Argentina, Brazil, Chile, and Dominican Republic
Product Description
Prismaflex Control Unit. Dialyzer, high permeability with or without sealed dialysate system. || Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/or fluid overload. *Therapeutic Plasma Exchange (TPE) therapy for patients weighing 20 kilograms or more with diseases where removal of plasma components is indicated.
Manufacturer
Baxter Healthcare Corporation

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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