AmeriWater Portable RO+, model numbers MR01 and MR02. The device is a reverse osmosis system for dialysis.
FDA device recall Z-0004-05 · posted 2004-10-05 · Terminated
Recall details
- Recalling firm
- Ameriwater Inc
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- FIP
- Quantity affected
- 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.
- Date initiated
- 2004-09-03
- Date posted
- 2004-10-05
- Date terminated
- 2007-01-26
- Location
- Dayton, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| KINETIC TECHNOLOGY PRECISION ADJUSTOR MOD. SHLCP-5 (K922695) | Kinetic Technology, Inc. | 1992-09-30 |