Mar Cor Purification CWP Reverse Osmosis System. Models 101, 102, 104, and 106
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| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1201-2014 | Class II | Terminated | Voluntary: Firm initiated |
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