Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported July 28, 2021
Citrasate Dry Acid Concentrate and GranuFlo Dry Acid Concentrate are each intended to be used as one component in the preparation of dialysate in a 3-stream proportioning hemodialysis machine according to a physician s prescription. Both concentrates are formulated for use in 45X proportioning systems which proportion a nominal ratio of 1 : 1.72 : 42.28 (acid : bicarbonate : water) to generate dialysate. The dialysate is intended to be pumped through a dialyzer, creating an osmotic gradient acro
Exposed to freezing temperatures due to refrigerated truck malfunctions
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Fresenius Medical Care Holdings, Inc. recalled Citrasate Dry Acid Concentrate and GranuFlo Dry Acid Concentrate are each intended to be … - a moderate-severity action.
Citrasate Dry Acid Concentrate and GranuFlo Dry Acid Concentrate are each intended to be … was recalled by Fresenius Medical Care Holdings, Inc. in July 28, 2021. Reason: Exposed to freezing temperatures due to refrigerated truck malfunctions. Check the official notice for the remedy. Verify recall #Z-2084-2021 with the FDA Devices before acting.
The recall
Fresenius Medical Care Holdings, Inc. issued this moderate-severity FDA Devices recall-Exposed to freezing temperatures due to refrigerated truck malfunctions.
- Moderate
- severity level
- Class II
- classification
- July 28, 2021
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2084-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2084-2021) was formally reported on July 28, 2021, with the manufacturer initiating the action on April 28, 2021. It is classified under Moderate severity (Class II), with a current status of Terminated. Fresenius Medical Care Holdings, Inc. is listed as the recalling firm, operating out of Waltham, MA. Federal records list the affected scope as (1) 40 cases (2) 3 cases (3) 4 cases.
The documented reason for this recall is: Exposed to freezing temperatures due to refrigerated truck malfunctions Distribution data in the federal record shows the product reached: US Distribution to: TX only. 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 moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
(1) 40 cases (2) 3 cases (3) 4 cases
Related Recalls
6
3 from same agency
Product description
Citrasate Dry Acid Concentrate and GranuFlo Dry Acid Concentrate are each intended to be used as one component in the preparation of dialysate in a 3-stream proportioning hemodialysis machine according to a physician s prescription. Both concentrates are formulated for use in 45X proportioning systems which proportion a nominal ratio of 1 : 1.72 : 42.28 (acid : bicarbonate : water) to generate dialysate. The dialysate is intended to be pumped through a dialyzer, creating an osmotic gradient across the dialyzer membrane to exchange solutes with blood during hemodialysis.
Reason for recall
Exposed to freezing temperatures due to refrigerated truck malfunctions
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2084-2021 |
| Date reported | July 28, 2021 |
| Date initiated | April 28, 2021 |
| Recalling firm | Fresenius Medical Care Holdings, Inc. |
| Firm location | Waltham, MA |
| Affected scope | (1) 40 cases (2) 3 cases (3) 4 cases |
| Distribution | US Distribution to: TX only |
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-2084-2021) 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? ▼
Citrasate Dry Acid Concentrate and GranuFlo Dry Acid Concentrate are each intended to be used as one component in the preparation of dialysate in a 3-stream proportioning hemodialysis machine according to a physician s prescription. Both concentrates are formulated for use in 45X proportioning systems which proportion a nominal ratio of 1 : 1.72 : 42.28 (acid : bicarbonate : water) to generate dialysate. The dialysate is intended to be pumped through a dialyzer, creating an osmotic gradient across the dialyzer membrane to exchange solutes with blood during hemodialysis.. Recalled by Fresenius Medical Care Holdings, Inc.. Units affected: (1) 40 cases (2) 3 cases (3) 4 cases.
Why was this product recalled? ▼
Exposed to freezing temperatures due to refrigerated truck malfunctions
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 28, 2021. Severity: Moderate. Recall number: Z-2084-2021.
Where was the recalled product distributed? ▼
Distribution: US Distribution to: TX only.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2084-2021) 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 July 28, 2021. 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.