MedRo Rx -Reverse Osmosis System All Models All Voltages, All Voltages
FDA device recall Z-0798-05 · posted 2005-05-06 · Terminated
Recall details
- Recalling firm
- U.S. Filter/Ionpure, Inc.
- Reason for recall
- Incorrect type of stainless steel firm used 303 vs 316
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- FIP
- Quantity affected
- 282 units
- Distribution
- Nationwide Foreign: Canada, Mexico
- Date initiated
- 2005-02-28
- Date posted
- 2005-05-06
- Date terminated
- 2012-05-15
- Location
- Lowell, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MEDRO SPD (K030652) | Usfilter/Ionpure, Inc. | 2003-09-03 |