Mar Cor Purification CWP Reverse Osmosis System. Models 101, 102, 104, and 106.

FDA device recall Z-1201-2014 · posted 2014-03-13 · Terminated

Recall details

Recalling firm

Mar Cor Purification

Reason for recall

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.

Action taken

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.

Root cause

Component design/selection

Status

Terminated

Product code

FIP

Quantity affected

130

Distribution

nationwide. No distribution outside the US.

Date initiated

2012-06-27

Date posted

2014-03-13

Date terminated

2014-08-22

Location

Minneapolis, MN

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