Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1201-2014Class II

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

Evoqua Water Technologies LLC / initiated 2012-06-27 / Terminated / root cause: design

Mar Cor Purification began a recall of Mar Cor Purification CWP Reverse Osmosis System. Models 101, 102, 104, and 106 on . FDA classified it as Class II and gives the reason as "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...". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-1201-2014
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Evoqua Water Technologies LLC
Product
Mar Cor Purification CWP Reverse Osmosis System. Models 101, 102, 104, and 106.
Product code
FIP Subsystem, Water 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.
Root cause tag
design
FDA 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 in commerce
130
Distribution
nationwide. No distribution outside the US.
Product codes and lots
serial numbers:  1289064, 1289069, 1289159, 1289259, 1289387, 1289650, 1289747, 1289826, 1289949, 1290088, 1290151, 1290333, 1290367, 1290480, 1290489, 1290845, 1290988, 1291042, 1291120, 1291233, 1291373, 1291378, 1291634, 1291777, 1291828, 1291933, 1292031, 1292114, 1292185, 1292185, 1292192, 1292391, 1292546, 1292597, 1292670, 1292674, 1292899, 1292960, 1293010, 1293039, 1293185, 1293190, 1293311, 1293379, 1293414, 1293687, 1293724, 1293771, 1293777, 1293953, 1293957, 1294093, 1294103, 1294171, 1294307, 1294362, 1294433, 1294516, 1294589, 1294727, 1294864, 1294999, 1295113, 1295137, 1295160, 1295186, 1295274, 1295391, 1295514, 1295622, 1295813, 1295871, 1296237, 1296241, 1296246, 1296484, 1296491, 1296582, 1296621, 1296650, 1296695, 1296806, 1297041, 1297046, 1297118, 1297231, 1297234, 1297372, 1297375, 1297394, 1297453, 1297484, 1297610, 1297655, 1297939, 1297943, 1298037, 1298210, 1298266, 1298270, 1298377, 1298407, 1298450, 1298457, 1298575, 1298619, 1298624, 1298704, 1298734, 1298797, 1298820, 1298879, 1298913, 1298952, 1298953, 1299037, 1299120, 1299144, 1299170, 1299241, 1299262, 1299285, 1299331, 1299393, 1299473, 1299512, 1299599, 1299655, 1299656, 1299732.

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1201-2014
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1201-2014Class IITerminatedVoluntary: Firm initiated