Events

Recall of Device Recall Mar Cor Purification Reverse Osmosis System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Mar Cor Purification.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    67516
  • Event Risk Class
    Class 2
  • Event Number
    Z-1201-2014
  • Event Initiated Date
    2012-06-27
  • Event Date Posted
    2014-03-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-08-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125653
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Water purification system for hemodialysis. - Product Code FIP
  • 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.
  • 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.

Device

Device Recall Mar Cor Purification Reverse Osmosis System
  • Model / Serial
    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.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    nationwide. No distribution outside the US.
  • Product Description
    Mar Cor Purification CWP Reverse Osmosis System. Models 101, 102, 104, and 106.
  • Manufacturer
    Mar Cor Purification

Manufacturer

Mar Cor Purification
  • Manufacturer Address
    Mar Cor Purification, 14550 28th Ave N, Minneapolis MN 55447-4817
  • Manufacturer Parent Company (2017)
    Cantel Medical Corp.
  • Source
    USFDA