Recall of DRIHEP PLUS* ARTERIAL BLOOD GAS SYRINGE KITS

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BECTON DICKINSON 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
    15909
  • Event Risk Class
    I
  • Event Initiated Date
    2000-04-14
  • Event Country
  • 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
    Lack of sterility assurance in clinipad swabs wipes and towelettes.

Device

  • Model / Serial
    Model Catalog: (Lot serial: DEV. LIC.# 7042); Model Catalog: (Lot serial: CAT.# 364971 LOT# 9D061); Model Catalog: (Lot serial: CAT.# 364962 LOT# 8G165 &); Model Catalog: (Lot serial: 9J206); Model Catalog: (Lot serial: CAT.# 364952 LOT# 9J205 &); Model Catalog: (Lot serial: CAT.# 375392 LOT 02028323A &); Model Catalog: (Lot serial: 02028292A); Model Catalog: (Lot serial: 9355522); Model Catalog: (Lot serial: CAT.# 375325 LOT# 02028294A &); Model Catalog: (Lot serial: 02028306A); Model Catalog: (Lot serial: CAT.# 375315 LOT# 02028306A)
  • Product Description
    ARTERIAL BLOOD GAS KITS
  • Manufacturer

Manufacturer