Recall Z-1201-2014— Mar Cor Purification

Name: FDA recall Z-1201-2014
Creator: U.S. Food and Drug Administration
Published: 2012-06-27

Class II · Terminated

Class II FDA medical device recall by Mar Cor Purification, initiated 2012-06-27, terminated 2014-08-22. It names one FDA 510(k) clearance: K974899. Product: Mar Cor Purification CWP Reverse Osmosis System. Models 101, 102, 104, and 106.. 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..

Recalling firm: Mar Cor Purification
Classification: Class II
Status: Terminated
Initiated: 2012-06-27
Terminated: 2014-08-22
Firm location: Minneapolis, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K974899 — GAMBRO CENTRAL WATER TREATMENT SYSTEM CWP 100 - WRO HGambro Healthcare·cleared 1998-09-23

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.