Events

Recall of Stryker Strykflow Suction Irrigation Tips

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Stryker Endoscopy.

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
    14462
  • Event Initiated Date
    2013-04-08
  • 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: Stryker New Zealand Ltd, 515 Mt Wellington Highway, Mt Wellington, AUCKLAND 1060
  • Reason
    The manufacturer has discovered that the temperatures listed for the pre-vacuum steam sterilization (wrapped method) did not match the validated temperatures for six out of the eleven languages. the pre-vacuum steam sterilization temperature in the instructions for use (ifu rev. k) incorrectly listed 121 - 123°c, instead of the correct 132 - 133°c.
  • Action
    Instructions for use to be updated

Device

Stryker Strykflow Suction Irrigation Tips
  • Model / Serial
    Model: Catalogue: 250070403, 250070404, 250070407, 250070408, 250070409, 250070437, 250070483, 250070484, 250070487, 250070488, 250070489, 250070490, Affected: Selected lot numbers
  • Manufacturer
    Stryker Endoscopy

Manufacturer

Stryker Endoscopy
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    NZMMDSA