Events

Recall of Sage Skin Products

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Sage Products 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
    20619
  • Event Initiated Date
    2016-09-08
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: Universal Specialities Ltd trading as USL Medical, 494 Rosebank Road, Avondale, AUCKLAND 1026
  • Reason
    Recall initiated due to potential product contamination with burkholderia cepacia. topical administration of a product with presence of microbial contamination may cause serious infections in immunocompromised persons and in hospitalised patients, as well as certain other patient groups.
  • Action
    Product to be returned to supplier

Device

Sage Skin Products
  • Model / Serial
    Model: 7453-X,7526-X, 7905-X,9601-X, 9602-X, Affected: Lot Numbers: 52297, 52427, 53031, 47656, 46885, 49019, 45445, 46854, 47582, 48307, 48999, 49716, 51611, 5280 and 53093
  • Manufacturer
    Sage Products Inc

Manufacturer

Sage Products Inc
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    NZMMDSA