Events

Recall of PERFEKTUM TUBERCULIN SYRINGES

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by SIGMA-ALDRICH CANADA CO..

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
    63014
  • Event Risk Class
    II
  • Event Initiated Date
    2015-08-11
  • 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
    Cadence science inc. was notified by a customer that the graduation marks of the syringe are not centered with the numeric position marks on the syringe barrel. while the graduation marks are correctly space for volume the numeric marks do not correctly align. this could cause the user to either under or over dose.

Device

PERFEKTUM TUBERCULIN SYRINGES
  • Model / Serial
    Model Catalog: 5202 (Lot serial: W003542/1); Model Catalog: 5202 (Lot serial: 79713-04); Model Catalog: 5202 (Lot serial: W006324/3); Model Catalog: 5209 (Lot serial: W002337/1); Model Catalog: 5208 (Lot serial: W002337/1); Model Catalog: 5209 (Lot serial: W002886/1); Model Catalog: 5208 (Lot serial: W006510/1); Model Catalog: 5209 (Lot serial: 80044-03); Model Catalog: 5208 (Lot serial: 80044-03); Model Catalog: 5209 (Lot serial: 71880-01); Model Catalog: 5208 (Lot serial: 71880-01); Model Catalog: 5209 (Lot serial: W006510/1); Model Catalog: 5208 (Lot serial: W002886/1)
  • Product Description
    PERFEKTUM TUBERCULIN SYRINGES
  • Manufacturer
    SIGMA-ALDRICH CANADA CO.

Manufacturer

SIGMA-ALDRICH CANADA CO.
  • Manufacturer Address
    OAKVILLE
  • Manufacturer Parent Company (2017)
    Merck KGaA
  • Source
    HC