Events

Recall of CADD - SOLIS VIP AMBULATORY INFUSION PUMP

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
    149857
  • Event Risk Class
    II
  • Event Initiated Date
    2015-05-27
  • 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 reports the intermittent occurrence of binding of the locking assembly on some cadd-solis pumps. binding on the cassette/keypad lock can occur after latching the cadd-solis medication cassette reservoir or administration set disposable to the pump. when binding occurs it can prevent the key from fully rotating the cassette/keypad lock to the locked (engaged) position. to start an infusion with pump models 2111 and 2112 and model 2120 when in pca mode the lock must be fully engaged. this issue is limited to specific serial numbers only (1061043 through 1067598).

Device

CADD - SOLIS VIP AMBULATORY INFUSION PUMP
  • Model / Serial
    Model Catalog: 21-2120-0102-02 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 21-2120-0102-51 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 21-2112-0300-50 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: 21-2111-0200-02 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: 21-2111-0300-02 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: 21-2111-0300-50 (Lot serial: >10 NUMBERS CONTACT MFR)
  • Product Description
    CADD-SOLIS VIP AMBULATORY INFUSION PUMP
  • Manufacturer
    SMITHS MEDICAL CANADA LTD. (SIMS)

Manufacturer

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