Severity
Low
LowClass IIITerminated
FDA Devices recall · Reported December 5, 2018
Fresenius Granuflo Dry Acid Concentrate- 3K 2.5 Ca 1 Mg 16.5 GAL Catalog Number: OFD3251-3B for hemodialysis
Discolored powder has confirmed the presence of a foreign substance
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Fresenius Medical Care Renal Therapies Group, LLC recalled Fresenius Granuflo Dry Acid Concentrate- 3K 2.5 Ca 1 Mg 16.5 GAL Catalog Number: OFD3… - a low-severity action.
Fresenius Granuflo Dry Acid Concentrate- 3K 2.5 Ca 1 Mg 16.5 GAL Catalog Number: OFD3… was recalled by Fresenius Medical Care Renal Therapies Group, LLC in December 5, 2018. Reason: Discolored powder has confirmed the presence of a foreign substance. Check the official notice for the remedy. Verify recall #Z-0518-2019 with the FDA Devices before acting.
The recall
Fresenius Medical Care Renal Therapies Group, LLC issued this low-severity FDA Devices recall-Discolored powder has confirmed the presence of a foreign substance.
- Low
- severity level
- 22K units
- affected scope
- Class III
- classification
- December 5, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0518-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0518-2019) was formally reported on December 5, 2018, with the manufacturer initiating the action on October 9, 2018. It is classified under Low severity (Class III), with a current status of Terminated. Fresenius Medical Care Renal Therapies Group, LLC is listed as the recalling firm, operating out of Waltham, MA. Federal records list the affected scope as 22320.
The documented reason for this recall is: Discolored powder has confirmed the presence of a foreign substance Distribution data in the federal record shows the product reached: Distribution US nationwide and Mexico. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
22320
Related Recalls
6
3 from same agency
Product description
Fresenius Granuflo Dry Acid Concentrate- 3K 2.5 Ca 1 Mg 16.5 GAL Catalog Number: OFD3251-3B for hemodialysis
Reason for recall
Discolored powder has confirmed the presence of a foreign substance
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | Z-0518-2019 |
| Date reported | December 5, 2018 |
| Date initiated | October 9, 2018 |
| Recalling firm | Fresenius Medical Care Renal Therapies Group, LLC |
| Firm location | Waltham, MA |
| Affected scope | 22320 |
| Distribution | Distribution US nationwide and Mexico |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0518-2019) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Fresenius Granuflo Dry Acid Concentrate- 3K 2.5 Ca 1 Mg 16.5 GAL Catalog Number: OFD3251-3B for hemodialysis. Recalled by Fresenius Medical Care Renal Therapies Group, LLC. Units affected: 22320.
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-0518-2019.
Where was the recalled product distributed? ▼
Distribution: Distribution US nationwide and Mexico.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0518-2019) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported December 5, 2018. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.