Events

Recall of NBP CUFF NEO SINGLE PATIENT USE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by DRAEGER MEDICAL CANADA INC..

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
    55479
  • Event Risk Class
    I
  • Event Initiated Date
    2010-06-30
  • 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
    Cases where measurements with the affected neonatal blood pressure cuffs deviate from the actual values. this deviation can be up to 50% meaning the measured and displayed value can be 50% higher than the actual one. an incorrect blood pressure reading can result in the neonatal patient being given the wrong medication and thus being exposed to risk.

Device

NBP CUFF NEO SINGLE PATIENT USE
  • Model / Serial
    Model Catalog: MP00901 (Lot serial: 12.01.2010 AND 12.06.2010); Model Catalog: MP00901 (Lot serial: DEVICES DELIVERED BETWEEN); Model Catalog: MP00902 (Lot serial: DEVICES DELIVERED BETWEEN); Model Catalog: MP00905 (Lot serial: 12.01.2010 AND 12.06.2010); Model Catalog: MP00904 (Lot serial: 12.01.2010 AND 12.06.2010); Model Catalog: MP00903 (Lot serial: 12.01.2010 AND 12.06.2010); Model Catalog: MP00902 (Lot serial: 12.01.2010 AND 12.06.2010); Model Catalog: MP00905 (Lot serial: DEVICES DELIVERED BETWEEN); Model Catalog: MP00904 (Lot serial: DEVICES DELIVERED BETWEEN); Model Catalog: MP00903 (Lot serial: DEVICES DELIVERED BETWEEN)
  • Product Description
    NBP CUFFS NEO SIZES 1 TO 5
  • Manufacturer
    DRAEGER MEDICAL CANADA INC.

Manufacturer

DRAEGER MEDICAL CANADA INC.