Events

Recall of SYNTRA DIALYZER 120

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
    21917
  • Event Risk Class
    II
  • Event Initiated Date
    2002-09-12
  • 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 received a small number of confirmed reports of saline and blood leaks from the header during priming of the dialyzer.

Device

SYNTRA DIALYZER 120
  • Model / Serial
    Model Catalog: R5M6243 (Lot serial: 4.); Model Catalog: R5M6246 (Lot serial: H02D26112 H02D21118 H02F2202); Model Catalog: R5M6243 (Lot serial: H02C20133 H02C20133A H02F110); Model Catalog: R5M6243 (Lot serial: 2C13112A H02C15083 H02C18152); Model Catalog: R5M6243 (Lot serial: 0102 H02B02018 H02C13112 H0); Model Catalog: R5M6243 (Lot serial: 5 H01L14048 H02A29138 H02A3); Model Catalog: R5M6243 (Lot serial: H01J13044 H01J15155 H01L1250); Model Catalog: R5M6243 (Lot serial: 3481 H01I27029 H01I29017A); Model Catalog: R5M6243 (Lot serial: H01G30068 H01H01075 H01H0203); Model Catalog: R5M6243 (Lot serial: 0040 H01E02129 H01G02067); Model Catalog: R5M6243 (Lot serial: 4 H01D09036 H01D10091 H01D3); Model Catalog: R5M6243 (Lot serial: h01c05093H01C26032 H01D0503); Model Catalog: R5M6243 (Lot serial: 2 H01H24077 H01H25025 H01I2); Model Catalog: R5M6243 (Lot serial: H02F17041 H02F18106 H02F1849); Model Catalog: R5M6246 (Lot serial: 02071 H02D07492 H02D22152); Model Catalog: R5M6246 (Lot serial: 64 H02C10506 H02C11561
  • Product Description
    SYNTRA 120 DIALYZER
  • Manufacturer
    BAXTER CORPORATION

Manufacturer

BAXTER CORPORATION