Events

Recall of CLOSED SYSTEM APHERESIS KIT

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
    53489
  • Event Risk Class
    I
  • Event Initiated Date
    2007-06-26
  • 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
    Manufacturer has become aware that the anticoagulant citrate dextrose and saline lines were reversed in assembly and may not be visually apparent in the monitor box-severe injury including death to the donor.

Device

CLOSED SYSTEM APHERESIS KIT
  • Model / Serial
    Model Catalog: 4R2180T (Lot serial: N05K09020); Model Catalog: 4R2180T (Lot serial: N06E22023); Model Catalog: 4R2180T (Lot serial: N05K18021); Model Catalog: 4R2180T (Lot serial: N05K29028); Model Catalog: 4R2180T (Lot serial: N05K01025); Model Catalog: 4R2180T (Lot serial: N05K08020); Model Catalog: 4R2180T (Lot serial: N06A20026); Model Catalog: 4R2180T (Lot serial: N06A24028); Model Catalog: 4R2180T (Lot serial: N06A26023); Model Catalog: 4R2180T (Lot serial: N06D17034); Model Catalog: 4R2180T (Lot serial: N06D24022); Model Catalog: 4R2180T (Lot serial: N06D26027); Model Catalog: 4R2180T (Lot serial: N06E16025); Model Catalog: 4R2180T (Lot serial: N05K11026); Model Catalog: 4R2180T (Lot serial: N07D18015); Model Catalog: 4R2180T (Lot serial: N07C23025); Model Catalog: 4R2180T (Lot serial: N07C09016); Model Catalog: 4R2180T (Lot serial: N07C07028); Model Catalog: 4R2180T (Lot serial: N07B13028); Model Catalog: 4R2180T (Lot serial: N07B07020); Model Catalog: 4R2180T (Lot serial: N07A24027); Model Catalog:
  • Product Description
    CLOSED SYSTEM APHERESIS KIT
  • Manufacturer
    BAXTER CORPORATION

Manufacturer

BAXTER CORPORATION