Recall of AUTO SYRINGE INFUSION PUMP - MODEL AS50A

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
    154507
  • Event Risk Class
    II
  • Event Initiated Date
    2008-09-02
  • 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
    The esd grounding squares were incorrectly placed on an as50 rear case assembly. the conductive copper side instead of the kapton side was incorrectly facing the i/o printed circuit board assembly.

Device

  • Model / Serial
    Model Catalog: 1M8550 (Lot serial: AAS5001530RP AAS5001531RP); Model Catalog: 1M8550R (Lot serial: AAS5001530RP AAS5001531RP)
  • Product Description
    REAR CASE ASSEMBLY FOR AUTO SYRINGE
  • Manufacturer

Manufacturer