Events

Recall of MEDICATION CASSETTE RESERVOIR

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

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
    44005
  • Event Risk Class
    II
  • Event Initiated Date
    2015-02-03
  • 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
    Smiths medical has received a small number of complaints of leakage in some cadd medication cassette reservoirs 50ml. a small amount of leaking has been found to occur at the welding of the tube to the internal reservoir bag on some cassettes. if noticed during cassette filling it could result in a delay of therapy while an alternative cassette is obtained. if noticed during fluid delivery with the patient it could result in an interruption in therapy while the cassette is replaced. smiths medical has received no reports of serious injury or death related to this issue.

Device

MEDICATION CASSETTE RESERVOIR
  • Model / Serial
    Model Catalog: 21-7001-24 (Lot serial: 14X-297); Model Catalog: 21-7301-24 (Lot serial: 14X-297); Model Catalog: 21-7001-24 (Lot serial: 14X-323); Model Catalog: 21-7301-24 (Lot serial: 14X-323); Model Catalog: 21-7001-24 (Lot serial: 14X-324); Model Catalog: 21-7301-24 (Lot serial: 14X-324)
  • Product Description
    CADD MEDICATION CASSETTE RESERVOIR50ML
  • Manufacturer
    SMITHS MEDICAL CANADA LTD. (SIMS)

Manufacturer

SMITHS MEDICAL CANADA LTD. (SIMS)
  • Manufacturer Address
    MARKHAM
  • Manufacturer Parent Company (2017)
    Smiths Group Plc
  • Source
    HC