Events

Recall of Clamps

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

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
    22557
  • Event Initiated Date
    2018-02-07
  • 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: B Braun New Zealand Ltd, 23 Falcon Street, Parnell, AUCKLAND 1052
  • Reason
    It has been determined that the plastic sleeves of the returned instrument do not meet the valid specification. instead of the specified material silicone, the material pvc was used for the manufacturing of the sleeves. this could render affected instruments unusable after reprocessing.
  • Action
    Product to be modified

Device

Clamps
  • Model / Serial
    Model: , Affected: STRAUSS PENIS CLAMP 130MM - EF401R
  • Manufacturer
    Aesculap AG

Manufacturer

Aesculap AG