Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported March 26, 2014
Mar Cor Purification Millenium HX Portable Reverse Osmosis System. Model 3025975. Product Usage: Water Purification System is intended to be used as a dialysis accessory to produce water through reverse osmosis for use with hemodialysis equipment..
High inlet water pressure beyond specification and the solenoid valve does not meet application which could result in a delay in treatment.
The recall
Mar Cor Purification issued this moderate-severity FDA Devices recall — High inlet water pressure beyond specification and the solenoid valve does not meet application which could r….
- Moderate
- severity level
- 232 units
- affected scope
- Class II
- classification
- March 26, 2014
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1213-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1213-2014) was formally reported on March 26, 2014, with the manufacturer initiating the action on June 26, 2013. It is classified under Moderate severity (Class II), with a current status of Terminated. Mar Cor Purification is listed as the recalling firm, operating out of Minneapolis, MN. Federal records list the affected scope as 232 units.
The documented reason for this recall is: High inlet water pressure beyond specification and the solenoid valve does not meet application which could result in a delay in treatment. Distribution data in the federal record shows the product reached: USA Nationwide Distribution including Puerto Rico.. 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, 6 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 — 27,303 medical devices recalls on record
Where this recall sits in the database
Of 83,949 recalls in the database, 21,198 are high severity, 58,883 moderate, and 3,868 low. This recall is classified moderate severity.
Affected scope
232 units
Related Recalls
6
6 from same agency
Product description
Mar Cor Purification Millenium HX Portable Reverse Osmosis System. Model 3025975. Product Usage: Water Purification System is intended to be used as a dialysis accessory to produce water through reverse osmosis for use with hemodialysis equipment..
Reason for recall
High inlet water pressure beyond specification and the solenoid valve does not meet application which could result in a delay in treatment.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1213-2014 |
| Date reported | March 26, 2014 |
| Date initiated | June 26, 2013 |
| Recalling firm | Mar Cor Purification |
| Firm location | Minneapolis, MN |
| Affected scope | 232 units |
| Distribution | USA Nationwide Distribution including Puerto Rico. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
Frequently Asked Questions
What product was recalled? ▼
Mar Cor Purification Millenium HX Portable Reverse Osmosis System. Model 3025975. Product Usage: Water Purification System is intended to be used as a dialysis accessory to produce water through reverse osmosis for use with hemodialysis equipment... Recalled by Mar Cor Purification. Units affected: 232 units.
Why was this product recalled? ▼
High inlet water pressure beyond specification and the solenoid valve does not meet application which could result in a delay in treatment.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 26, 2014. Severity: Moderate. Recall number: Z-1213-2014.
Where was the recalled product distributed? ▼
Distribution: USA Nationwide Distribution including Puerto Rico..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1213-2014) 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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Data Sources
Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Devices, reported March 26, 2014.
- Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Read our methodology — how this data is sourced, computed, and verified.
Source: Federal recall agencies (FDA, CPSC, NHTSA) Aggregated federal recall feeds Recall data normalized across FDA, CPSC and NHTSA feeds; severity classifications follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type).