Fresenius Granuflo Dry Acid Concentrate Recalled for Foreign Substance
Fresenius Medical Care is recalling specific lots of Granuflo Dry Acid Concentrate for hemodialysis due to the presence of a foreign substance.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The agency classified this as a Class III recall, which is defined as unlikely to cause adverse health consequences. The hazard is a foreign substance without reported injuries or illnesses.
Plain-English summary
Fresenius Medical Care Renal Therapies Group, LLC is recalling 92,225 units of Fresenius Granuflo Dry Acid Concentrate- 2K 2.5 Ca 1 Mg 16.5 GAL (Catalog Number: OFD2251-3B). The product is used for hemodialysis and was distributed nationwide in the United States and in Mexico.
The recall was initiated because discolored powder was found in the product, which confirmed the presence of a foreign substance. The affected lots are 18ETGF010, 18HTGF002, 18HTGF003, 18HTGF007, 18HTGF011, 18HTGF013, 18HTGF016, 18JTGF005, 18JTGF010, 18JTGF012, 18KTGF001, and 18KTGF011.
Healthcare facilities and consumers should stop using the affected product and contact the recalling firm for further instructions.
The recalled product
- Product
- Fresenius Granuflo Dry Acid Concentrate- 2K 2.5 Ca 1 Mg 16.5 GAL Catalog Number: OFD2251-3B for hemodialysis
- Hazard
- Affected units
- 92,225
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Fresenius Medical Care Renal Therapies Group, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
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