Events

Recall of SERATRONICS DIALYZER PREPARATION SYSTEM

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

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
    66314
  • Event Risk Class
    II
  • Event Initiated Date
    2013-01-13
  • 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
    Conmed received five complaints of some devices which had broken through the seal of the sterile pouch: the initial complaint was received on november 30 2012. conmed has confirmed instances where the pouch seal was compromised on the affected products. in no instance has it been reported to conmed corporation that a compromise in the sterile barrier has resulted in illness or injury. the compromised seals were discovered prior to use.

Device

SERATRONICS DIALYZER PREPARATION SYSTEM
  • Model / Serial
    Model Catalog: 130343 (Lot serial: 120628X - 120917X); Model Catalog: 138025 (Lot serial: 120628X - 120917X); Model Catalog: 137668 (Lot serial: 120628X - 120917X); Model Catalog: 139105EXT (Lot serial: 120628X - 120917X); Model Catalog: 139104EXT (Lot serial: 120628X - 120917X); Model Catalog: 139102 (Lot serial: 120628X - 120917X); Model Catalog: 139112 (Lot serial: 120628X - 120917X); Model Catalog: 7-100-8BX (Lot serial: 120628X - 120917X); Model Catalog: 7-101-8BX (Lot serial: 120628X - 120917X); Model Catalog: 139107 (Lot serial: 120628X - 120917X)
  • Product Description
    Single Use ABC Nozzle Sterile (For use with 130500 Reusable ABC Handpiece)
  • Manufacturer
    CONMED CANADA

Manufacturer

CONMED CANADA
  • Manufacturer Address
    MISSISSAUGA
  • Manufacturer Parent Company (2017)
    CONMED Corp.
  • Source
    HC