AmeriWater Portable RO+, model numbers MR01 and MR02. The device is a reverse osmosis system for dialysis.
FDA Recall Z-0004-05 · Posted 2004-10-05
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Recalling FirmAmeriwater Inc
Recall StatusTerminated
Product CodeFIP
Date Initiated2004-09-03
Date Terminated2007-01-26
Product Quantity148 units.
Reason for Recall
The device has a potential risk of failure caused by faulty wiring within the electrical component. The wires can overheat and eventually break in two.
Firm Action
The firm notified consignee''s via letter sent on September 3, 2004. Consignees were provided in the letter with written instructions to correct the problem and were instructed to fax a return response form identifying that the corrections had been completed.
Root Cause
Other
Distribution Pattern
Product was distributed in the following states: MI, HI, PA, IL, CA, CO, OH, TX, NY, SD, ON, IN, NC, MN, KY, SC, TN, FL, NJ, GA, MD, DE, AR, and MA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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