Fresenius Granuflo Dry Acid Concentrate- 2K 2.0 Ca 1 Mg 16.5 GAL Catalog Number: OFD2201-3B for hemodialysis
Reported: December 5, 2018 Initiated: October 9, 2018 #Z-0516-2019
Product Description
Fresenius Granuflo Dry Acid Concentrate- 2K 2.0 Ca 1 Mg 16.5 GAL Catalog Number: OFD2201-3B for hemodialysis
Reason for Recall
Discolored powder has confirmed the presence of a foreign substance
Details
- Recalling Firm
- Fresenius Medical Care Renal Therapies Group, LLC
- Units Affected
- 4752
- Distribution
- Distribution US nationwide and Mexico
- Location
- Waltham, MA
Frequently Asked Questions
What product was recalled? ▼
Fresenius Granuflo Dry Acid Concentrate- 2K 2.0 Ca 1 Mg 16.5 GAL Catalog Number: OFD2201-3B for hemodialysis. Recalled by Fresenius Medical Care Renal Therapies Group, LLC. Units affected: 4752.
Why was this product recalled? ▼
Discolored powder has confirmed the presence of a foreign substance
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 5, 2018. Severity: Low. Recall number: Z-0516-2019.
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