Mar Cor Purification Millenium HX Portable Reverse Osmosis System Recalled
Mar Cor Purification is recalling 232 Millenium HX Portable Reverse Osmosis Systems due to high inlet water pressure and solenoid valve issues that could delay dialysis treatment.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device used for dialysis where a defect could result in a delay in treatment, fitting the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Mar Cor Purification is recalling 232 units of the Millenium HX Portable Reverse Osmosis System, Model 3025975. The product is a water purification system intended to be used as a dialysis accessory to produce water through reverse osmosis for use with hemodialysis equipment.
The recall was initiated because high inlet water pressure beyond specification and the solenoid valve not meeting application requirements could result in a delay in treatment. The affected units were distributed nationwide in the USA, including Puerto Rico.
Consumers should check the serial number of their device against the list of affected serial numbers provided in the official recall notice. If the serial number matches, users should contact Mar Cor Purification for instructions on how to proceed.
The recalled product
- Product
- 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..
- Manufacturer
- Mar Cor Purification
- Affected units
- 232
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Serial Numbers: 1294627
- 1298383
- 1298386
- 1299352
- 1299353
- 1299354
- 1299355
- 1299356
- 1299486
- 1299487
- 1299488
- 1299489
- 1299503
- 1299572
- 1299712
- 1299713
- 1299716
- 1299718
- 1299719
- 1299720
Distribution
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