Events

Recall of DERMAHOOK SKIN RETRACTOR

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

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
    51245
  • Event Risk Class
    II
  • Event Initiated Date
    2008-08-12
  • 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
    The elastic bands are breaking within the sealed packaging prior to expiration dates. customers are storing them in a controlled environment within temperature limits but they are still breaking prematurely.

Device

DERMAHOOK SKIN RETRACTOR
  • Model / Serial
    Model Catalog: CATALOG # 382805 (Lot serial: > 10 lot# contact manufact.); Model Catalog: CATALOG # 382800 (Lot serial: > 10 lot# contact manufact); Model Catalog: CATALOG # 382800 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: CATALOG # 382805 (Lot serial: >10 NUMBERS CONTACT MFR)
  • Product Description
    Dermahook Neuro Elastic Retractors1/2''
  • Manufacturer
    TELEFLEX MEDICAL

Manufacturer

TELEFLEX MEDICAL