Events

Recall of STOPCOCK GANG

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

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
    73286
  • Event Risk Class
    II
  • 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
    Icu medical inc. has identified certain stopcocks that are incorporated in i.V sets may contain a metallic burr. out of an abundance of caution icu medical inc. is voluntarily recalling the affected devices. the company has not received complaints or reports of any patient injury associated with this issue.

Device

STOPCOCK GANG
  • Model / Serial
    Model Catalog: B4154 (Lot serial: 3447427); Model Catalog: B4020 (Lot serial: 3456237); Model Catalog: B4020 (Lot serial: 3486340); Model Catalog: B30243 (Lot serial: 3465813)
  • Product Description
    3 GANG 3-WAY STOPCOCKS W/ROTATING LUER;3-WAY HIGH FLOW STOPCOCK W/ROTATING LUER;32"(81 CM) TRANSFER SET W/3-WAY STOPCOCK CLAMP ROTATING LUER NON-DEHP TUBING
  • Manufacturer
    ICU MEDICAL INC.

Manufacturer

ICU MEDICAL INC.
  • Manufacturer Address
    SAN CLEMENTE
  • Manufacturer Parent Company (2017)
    ICU Medical, Inc.
  • Source
    HC