Events

Recall of AMIA AUTOMATED PD SET WITH CASSETTE (DISPOSABLE SET)

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
    56153
  • Event Risk Class
    I
  • Event Initiated Date
    2017-09-06
  • 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
    Baxter corporation is issuing a product recall for certain lots of the amia automated peritoneal dialysis set with cassette in response to increased customer complaints received for missing red line patient slow flow solution slow flow and inadequate drain alerts. increased frequency of these alerts could lead to insufficient draining of waste solution which can be a contributing factor in fluid overload.

Device

AMIA AUTOMATED PD SET WITH CASSETTE (DISPOSABLE SET)
  • Model / Serial
    Model Catalog: 5C5479 (Lot serial: H16J05035); Model Catalog: 5C5479 (Lot serial: H16I21058); Model Catalog: 5C5479 (Lot serial: H16I14103); Model Catalog: 5C5479 (Lot serial: H16I02017); Model Catalog: 5C5479 (Lot serial: H16H26034); Model Catalog: 5C5479 (Lot serial: H16H09063); Model Catalog: 5C5479 (Lot serial: H16H04114); Model Catalog: 5C5479 (Lot serial: H16J07015); Model Catalog: 5C5479 (Lot serial: H16H30010)
  • Product Classification
    Gastroenterology-Urology Devices
  • Product Description
    AMIA AUTOMATED PERITONEAL DIALYSIS SET WITH CASSETTE
  • Manufacturer
    BAXTER CORPORATION

Manufacturer

BAXTER CORPORATION