Fresenius Granuflo Dry Acid Concentrate Recalled for Foreign Substance
Fresenius Medical Care is recalling Granuflo Dry Acid Concentrate for hemodialysis due to confirmed foreign substance contamination.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk medical device (hemodialysis concentrate) with a confirmed foreign substance, but the source text does not report any illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Fresenius Medical Care Renal Therapies Group, LLC is recalling 22,320 units of Fresenius Granuflo Dry Acid Concentrate (Catalog Number: OFD3251-3B) used for hemodialysis. The recall was initiated because discolored powder was found in the product, which confirmed the presence of a foreign substance.
The affected lots are 18BTGF016, 18ETGF006, 18ETGF014, 18HTGF015, and 18LTGF003. These products were distributed nationwide in the United States and in Mexico.
Patients and healthcare facilities should stop using the affected lots immediately and contact their supplier or Fresenius Medical Care for further instructions.
The recalled product
- Product
- Fresenius Granuflo Dry Acid Concentrate- 3K 2.5 Ca 1 Mg 16.5 GAL Catalog Number: OFD3251-3B for hemodialysis
- Affected units
- 22,320
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot code: 18BTGF016 18ETGF006 18ETGF014 18HTGF015 18LTGF003
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.
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