Recall Z-0004-05 ยท FIP Subsystem, Water Purification
Ameriwater Inc
AmeriWater Portable RO+, model numbers MR01 and MR02. The device is a reverse osmosis system for dialysis.
| Date | Oct 5, 2004 (initiated Sep 3, 2004) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| 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. |
| Quantity | 148 units. |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K922695 | KINETIC TECHNOLOGY PRECISION ADJUSTOR MOD. SHLCP-5 Kinetic Technology, Inc., Sep 30, 1992 |