Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported May 6, 2015
2008 Series Hemodialysis Machines: 2008T with the following product code and description: 190395 2008K at Home System - 1st Gen. -¿ Canada; 190828 2008K at Home System - 2nd Gen - U.S.; 190904 2008K at Home System w/ Bibag; 190828 2008KatHOME HEMODIALYSIS SYSTEM; 190395 2008KatHOME MACHINE, SHORT CAB, OLC/DP, HP The Fresenius 2008K is indicated for acute and chronic dialysis therapy.
The Acetate value for GranuFlo on the Select Concentrate screen should be 8mEq/l but it is displayed as 4mEq/l. The correct value is shown on the dialysate screen.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Fresenius Medical Care Holdings, Inc. recalled 2008 Series Hemodialysis Machines: 2008T with the following product code and description:… - a moderate-severity action.
2008 Series Hemodialysis Machines: 2008T with the following product code and description:… was recalled by Fresenius Medical Care Holdings, Inc. in May 6, 2015. Reason: The Acetate value for GranuFlo on the Select Concentrate screen should be 8mEq/l but it is displayed as 4mEq/…. Check the official notice for the remedy. Verify recall #Z-1550-2015 with the FDA Devices before acting.
The recall
Fresenius Medical Care Holdings, Inc. issued this moderate-severity FDA Devices recall-The Acetate value for GranuFlo on the Select Concentrate screen should be 8mEq/l but it is displayed as 4mEq/….
- Moderate
- severity level
- Class II
- classification
- May 6, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1550-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1550-2015) was formally reported on May 6, 2015, with the manufacturer initiating the action on February 20, 2015. 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 133,751 in total (US: 130,337 and OUS: Canada 1,201 and Mexico 2,213).
The documented reason for this recall is: The Acetate value for GranuFlo on the Select Concentrate screen should be 8mEq/l but it is displayed as 4mEq/l. The correct value is shown on the dialysate screen. Distribution data in the federal record shows the product reached: Worldwide Distribution: US (Nationwide) and countries of: Canada 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 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
133,751 in total (US: 130,337 and OUS: Canada 1,201 and Mexico 2,213)
Related Recalls
6
3 from same agency
Product description
2008 Series Hemodialysis Machines: 2008T with the following product code and description: 190395 2008K at Home System - 1st Gen. -¿ Canada; 190828 2008K at Home System - 2nd Gen - U.S.; 190904 2008K at Home System w/ Bibag; 190828 2008KatHOME HEMODIALYSIS SYSTEM; 190395 2008KatHOME MACHINE, SHORT CAB, OLC/DP, HP The Fresenius 2008K is indicated for acute and chronic dialysis therapy.
Reason for recall
The Acetate value for GranuFlo on the Select Concentrate screen should be 8mEq/l but it is displayed as 4mEq/l. The correct value is shown on the dialysate screen.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1550-2015 |
| Date reported | May 6, 2015 |
| Date initiated | February 20, 2015 |
| Recalling firm | Fresenius Medical Care Holdings, Inc. |
| Firm location | Waltham, MA |
| Affected scope | 133,751 in total (US: 130,337 and OUS: Canada 1,201 and Mexico 2,213) |
| Distribution | Worldwide Distribution: US (Nationwide) and countries of: Canada 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-1550-2015) 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? ▼
2008 Series Hemodialysis Machines: 2008T with the following product code and description: 190395 2008K at Home System - 1st Gen. -¿ Canada; 190828 2008K at Home System - 2nd Gen - U.S.; 190904 2008K at Home System w/ Bibag; 190828 2008KatHOME HEMODIALYSIS SYSTEM; 190395 2008KatHOME MACHINE, SHORT CAB, OLC/DP, HP The Fresenius 2008K is indicated for acute and chronic dialysis therapy.. Recalled by Fresenius Medical Care Holdings, Inc.. Units affected: 133,751 in total (US: 130,337 and OUS: Canada 1,201 and Mexico 2,213).
Why was this product recalled? ▼
The Acetate value for GranuFlo on the Select Concentrate screen should be 8mEq/l but it is displayed as 4mEq/l. The correct value is shown on the dialysate screen.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 6, 2015. Severity: Moderate. Recall number: Z-1550-2015.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution: US (Nationwide) and countries of: Canada and Mexico..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1550-2015) 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 May 6, 2015. 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.