Food, drugs, devices › Fresenius Medical Care Renal Therapies Group, LLC
Device recall: Fresenius Granuflo Dry Acid Concentrate- 2K 2.0 Ca 1 Mg 16.5 GAL Catalog Number: OFD2201-3B for hemodialysis
Fresenius Medical Care Renal Therapies Group, LLC (Waltham, MA) initiated this device recall on 9 Oct 2018; FDA lists 3 product records under event 81451, classified Class III.
FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 4% of the 1,074 device enforcement events initiated in 2018 carry the same class.
Status: Terminated, terminated 5 Aug 2021. Initiation: voluntary: firm initiated. Fresenius Medical Care Renal Therapies Group, LLC has 22 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Fresenius Medical Care Renal Therapies Group, LLC, Waltham, MA.
Reason for recall
"Discolored powder has confirmed the presence of a foreign substance"
Distribution
"Distribution US nationwide and Mexico"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0516-2019 | Fresenius Granuflo Dry Acid Concentrate- 2K 2.0 Ca 1 Mg 16.5 GAL Catalog Number: OFD2201-3B for hemodialysis | 4752 | Class III | Terminated | 5 Dec 2018 |
| Z-0517-2019 | Fresenius Granuflo Dry Acid Concentrate- 2K 2.5 Ca 1 Mg 16.5 GAL Catalog Number: OFD2251-3B for hemodialysis | 92225 | Class III | Terminated | 5 Dec 2018 |
| Z-0518-2019 | Fresenius Granuflo Dry Acid Concentrate- 3K 2.5 Ca 1 Mg 16.5 GAL Catalog Number: OFD3251-3B for hemodialysis | 22320 | Class III | Terminated | 5 Dec 2018 |
Context
Other enforcement events for Fresenius Medical Care Renal Therapies Group, LLC
All 22 events for Fresenius Medical Care Renal Therapies Group, LLC
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Discolored powder has confirmed the presence of a foreign substance"
What does Class III mean?
FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Where was the product distributed?
FDA's distribution pattern field reads: "Distribution US nationwide and Mexico"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 5 Aug 2021. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.