FDAFDA · Alimentos y medicamentos·N.º oficial Z-1201-2014
Mar Cor Purification CWP Reverse Osmosis System. Models 101, 102, 104, and 106.
Publicado el 19 de marzo de 2014 · Inicio del retiro: 27 de junio de 2012
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
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.
Qué hacer
Voluntary: Firm initiated · Telephone
Detalles del retiro
- Fabricante
- Mar Cor Purification
- Distribuidor
- nationwide. No distribution outside the US.
- Lote
- 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.
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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