Fresenius 132 Gallon GranuFlo Dissolution Unit - P/N G047-80101. For Use in the Preparation of acid concentrate for hemodialysis.
Reported: November 25, 2015 Initiated: October 23, 2015 #Z-0294-2016
Product Description
Fresenius 132 Gallon GranuFlo Dissolution Unit - P/N G047-80101. For Use in the Preparation of acid concentrate for hemodialysis.
Reason for Recall
Dissolution units and replacement motors units do not provide full thermal protection for both the Main and Starter coils resulting in the generation of smoke and/or potentially lead to fire.
Details
- Recalling Firm
- Fresenius Medical Care Renal Therapies Group, LLC
- Units Affected
- 918 units
- Distribution
- Nationwide Distribution.
- Location
- Waltham, MA
Frequently Asked Questions
What product was recalled? ▼
Fresenius 132 Gallon GranuFlo Dissolution Unit - P/N G047-80101. For Use in the Preparation of acid concentrate for hemodialysis.. Recalled by Fresenius Medical Care Renal Therapies Group, LLC. Units affected: 918 units.
Why was this product recalled? ▼
Dissolution units and replacement motors units do not provide full thermal protection for both the Main and Starter coils resulting in the generation of smoke and/or potentially lead to fire.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 25, 2015. Severity: Moderate. Recall number: Z-0294-2016.
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