Events

Recall of TEOSYAL PURESENSE REDENSITY II

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by CLARION MEDICAL TECHNOLOGIES INC..

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
    16025
  • Event Risk Class
    II
  • Event Initiated Date
    2014-06-06
  • 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
    A foreign incident involving a 48 year old female with a known history of severe allergies was injected with teosyal causing anaphylactic shock (a known and listed contra-indication). while there are no product specific issues the amending of the ifu's (to include anaphylactic shock in the side effects section) has resulted in the classification of a recall.

Device

TEOSYAL PURESENSE REDENSITY II
  • Model / Serial
    Model Catalog: TEOSYAL PURESENSE REDENSITY II (Lot serial: all); Model Catalog: TEOSYAL PURESENSE REDENSITY II (BD) (Lot serial: all); Model Catalog: TEOSYAL PURESENSE REDENSITY II (TSK) (Lot serial: all); Model Catalog: TEOSYAL PURESENSE ULTRA DEEP (1.2ML) (TR) (Lot serial: all); Model Catalog: TEOSYAL PURESENSE ULTRA DEEP (TR) (Lot serial: all); Model Catalog: TEOSYAL PURESENSE ULTRA DEEP (TSK) (Lot serial: all); Model Catalog: TEOSYAL PURESENSE ULTRA DEEP (1.2ML) (TSK) (Lot serial: all); Model Catalog: TEOSYAL PURESENSE FIRST LINES (BD) (Lot serial: all); Model Catalog: TEOSYAL PURESENSE DEEP LINES (TSK) (Lot serial: all); Model Catalog: TEOSYAL PURESENSE KISS (TR) (Lot serial: all); Model Catalog: TEOSYAL PURESENSE KISS (TSK) (Lot serial: all); Model Catalog: TEOSYAL PURESENSE FIRST LINE (TSK) (Lot serial: all); Model Catalog: TEOSYAL PURESENSE DEEP LINES (TR) (Lot serial: all); Model Catalog: TEOSYAL PURESENSE GLOBAL ACTION (TSK) (Lot serial: all); Model Catalog: TEOSYAL PURESENSE GLOBAL ACTION (TR) (Lo
  • Product Description
    TEOSYAL PURESENSE REDENSITY II
  • Manufacturer
    CLARION MEDICAL TECHNOLOGIES INC.

Manufacturer

CLARION MEDICAL TECHNOLOGIES INC.