Recall Z-1201-2014 ยท FIP Subsystem, Water Purification
Mar Cor Purification
Mar Cor Purification CWP Reverse Osmosis System. Models 101, 102, 104, and 106.
| Date | Mar 13, 2014 (initiated Jun 27, 2012) |
| Status | Terminated |
| Reason | There exists a potential situation with the crimp connection at the pump head assembly. The potential exists that the reverse osmosis pump head wiring could build resistance resulting in resistive heating of the surrounding components. If this occurs, the pump head assembly may experience melting of the plastic components and potentially create smoke/fire and shut down of the unit. |
| Root cause | Component design/selection |
| Action | Mar Cor Technicians started visiting the consignees to make the correction, in June 2012 Mar Cor called the consignee prior to the visit. An Urgent Medical Device correction letter was sent to customers beginning 2/27/2014. the letter identified the affected units, described the issue, stated that a correction has been, or will be made to the devices and asked for a response form be sent back to the firm. |
| Quantity | 130 |
| Distribution | nationwide. No distribution outside the US. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K974899 | GAMBRO CENTRAL WATER TREATMENT SYSTEM CWP 100 - WRO H Gambro Healthcare, Sep 23, 1998 |