Events

Recall of DRY LINE DRAW PLUS ARTERIAL BLOOD SAMPLING KIT

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

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
    54623
  • Event Risk Class
    III
  • Event Initiated Date
    2013-11-14
  • 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
    Smith medical has identified an issue with abl syringes when used with radiometer brand blood gas analyzers. in august 2013 smiths medical began receiving a small number of complaints regarding use of the abl syringes with radiometer blood analyzers. the plunger tip in the abl syringe does not remain stationary when the probe of the analyzer extends into the syringe. this allows air to leak into the sample at the luer stopping the blood from entering the analyzer probe and preventing the analysis of blood. this can result in difficulties aspirating the sample or the plunger may get pushed out of the syringe. smiths medical has received no reports of injury associated with this issue.

Device

DRY LINE DRAW PLUS ARTERIAL BLOOD SAMPLING KIT
  • Model / Serial
    Model Catalog: 4043-2 (Lot serial: >1000 NUMBERS CONTACT MFG); Model Catalog: G1762 (Lot serial: >1000 NUMBERS CONTACT MFG); Model Catalog: 4042-2 (Lot serial: >1000 NUMBERS CONTACT MFG); Model Catalog: 4042LH (Lot serial: >1000 NUMBERS CONTACT MFG); Model Catalog: G1777 (Lot serial: >1000 NUMBERS CONTACT MFG); Model Catalog: 4040-2 (Lot serial: >1000 NUMBERS CONTACT MFG)
  • Product Description
    DRY LINE DRAW PLUS ARTERIAL BLOOD SAMPLING KIT
  • Manufacturer
    SMITHS MEDICAL CANADA LTD. (SIMS)

Manufacturer

SMITHS MEDICAL CANADA LTD. (SIMS)
  • Manufacturer Address
    MARKHAM
  • Manufacturer Parent Company (2017)
    Smiths Group Plc
  • Source
    HC