Events

Recall of CWP 60 SYSTEM (CENTRAL WATER TREATMENT SYSTEM FOR HEMODIALYSIS)

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BAXTER CORPORATION.

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
    71414
  • Event Risk Class
    II
  • Event Initiated Date
    2016-11-21
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Baxter corporation is issuing a device correction for specific models of the central water plant (cwp) reverse osmosis units in order to correct the insufficient crimping of the cables within the main pump. the issue was identified as a result of customer complaints received for the presence of smoke in the water treatment room due to the overheating of the pump in the cwp. as part of baxter's investigation based on pictures provided from the event the most likely cause of the thermal event was due to the crimp of the cables for the main pump being insufficient. to minimize any potential side effects of thermal events please ensure all panels of the cwp are in place.

Device

CWP 60 SYSTEM (CENTRAL WATER TREATMENT SYSTEM FOR HEMODIALYSIS)
  • Model / Serial
    Model Catalog: WRO63 (Lot serial: > 100 numbers contact mfg); Model Catalog: WRO 106H (Lot serial: > 100 numbers contact mfg); Model Catalog: WRO 104S (Lot serial: > 100 numbers contact mfg); Model Catalog: WRO112 (Lot serial: > 100 numbers contact mfg); Model Catalog: WRO113 (Lot serial: > 100 numbers contact mfg); Model Catalog: WRO111 (Lot serial: > 100 numbers contact mfg); Model Catalog: WRO102H (Lot serial: > 100 numbers contact mfg); Model Catalog: WRO103S (Lot serial: > 100 numbers contact mfg); Model Catalog: WRO101H (Lot serial: > 100 numbers contact mfg); Model Catalog: WRO104H (Lot serial: > 100 numbers contact mfg); Model Catalog: WRO103H (Lot serial: > 100 numbers contact mfg); Model Catalog: WRO 106S (Lot serial: > 100 numbers contact mfg); Model Catalog: WRO102S (Lot serial: > 100 numbers contact mfg); Model Catalog: WRO101S (Lot serial: > 100 numbers contact mfg); Model Catalog: WRO103H(P) (Lot serial: > 100 numbers contact mfg); Model Catalog: WRO102H(P) (Lot serial: > 100 numbers contact m
  • Product Description
    Central Water Plant Reverse Osmosis Unit (CWP 60);Central Water Plant Reverse Osmosis Unit (CWP 100)
  • Manufacturer
    BAXTER CORPORATION

Manufacturer

BAXTER CORPORATION