Events

Recall of CADD-PRIZM HIGH VOLUME ADMINISTRATION SET

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
    28217
  • Event Risk Class
    II
  • Event Initiated Date
    2012-03-21
  • 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 total of 22 complaints regarding occlusions/high pressure alarms experienced with cadd high volume administration sets 21-7081v-01 and 21-7381-01. please note 21-7081v-01 is not sold in canada. investigation of this issue has identified the root cause to be related to the incorrect filter size being used in one lot of finished goods. investigation to the root cause identified that the supplier had supplied a 0.2u filter instead of a 1.2 u filter. the 0.2u filter does not allow for the passage of lipids in tpn solution whereas the 1.2u filter does allow the passage of lipids. an indepth investigation concluded that the incorrect filter size was limited to 2 component part lot numbers which were put into production of 2 smiths medical finished goods lot numbers. only 1 lot number 21x221 applies to canadian product.

Device

CADD-PRIZM HIGH VOLUME ADMINISTRATION SET
  • Model / Serial
    Model Catalog: 21-7381-01 (Lot serial: 21X221)
  • Product Description
    CADD High Volume Administration Sets
  • Manufacturer
    SMITHS MEDICAL CANADA LTD. (SIMS)

Manufacturer

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