Events

Recall of BASIC ADMINISTRATION SETS

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by THE STEVENS COMPANY LIMITED.

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
    50810
  • Event Risk Class
    II
  • Event Initiated Date
    2003-01-22
  • 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
    Sterile sets with a particular drip chamber configuation could possibly leak or have the attached tubing disconnect from the drip chamber.

Device

BASIC ADMINISTRATION SETS
  • Model / Serial
    Model Catalog: V1402 (Lot serial: 60191271 60202067 60207552); Model Catalog: V1402 (Lot serial: 60174098 60175198 60187747); Model Catalog: V1402 (Lot serial: 60209170 60211435 60219582); Model Catalog: V1402 (Lot serial: 60242035 60248970.); Model Catalog: V1415 (Lot serial: 60206699 60224041 60180838); Model Catalog: V1418 (Lot serial: 60206699 60224041 60180838); Model Catalog: V1415 (Lot serial: 60164609 60171369 60183966); Model Catalog: V1418 (Lot serial: 60164609 60171369 60183966); Model Catalog: V1415 (Lot serial: 60193556 60206694 60211432); Model Catalog: V1418 (Lot serial: 60193556 60206694 60211432); Model Catalog: V1415 (Lot serial: 60216148 60228145 60258133.); Model Catalog: V1418 (Lot serial: 60216148 60228145 60258133.); Model Catalog: V1464 (Lot serial: 60162121 60073185 60104261.); Model Catalog: V1443 (Lot serial: 60162121 60073185 60104261.)
  • Product Description
    BASIC IV SET
  • Manufacturer
    THE STEVENS COMPANY LIMITED

Manufacturer

THE STEVENS COMPANY LIMITED