Recall Z-0798-05 ยท FIP Subsystem, Water Purification
U.S. Filter/Ionpure, Inc.
MedRo Rx -Reverse Osmosis System All Models All Voltages, All Voltages
| Date | May 6, 2005 (initiated Feb 28, 2005) |
| Status | Terminated |
| Reason | Incorrect type of stainless steel firm used 303 vs 316 |
| Root cause | Other |
| Action | US Filter notified consignees by letter between 3/17 and 3/28/05 advising users of the recall.US Service will field correct and replace units. |
| Quantity | 282 units |
| Distribution | Nationwide Foreign: Canada, Mexico |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K030652 | MEDRO SPD Usfilter/Ionpure, Inc., Sep 3, 2003 |