Events

Recall of Peters Surgical Cardioxyl Sutures

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

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
    16859
  • Event Initiated Date
    2014-06-19
  • 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: Obex Medical Ltd, 303 Manukau Road, Epsom, AUCKLAND
  • Reason
    A potential splitting of the surface treatment of the thread ends on certain sutures has recently been identified. this treatment substance aims at easing the crimping process of our needles. this treatment is only applied on the area where the thread is in contact with the needle: meaning on 1(one) centimetre from the end of the thread approximately. the treated ends are clearly out of the implanted section of the thread.
  • Action
    Product to be returned to supplier

Device

Peters Surgical Cardioxyl Sutures
  • Model / Serial
    Model: Catalogue Numbers: 73I30AZ, 73P30U, 73S30AY, Affected: Lots: 967180; 957090 & 04168; 909630 respectively
  • Manufacturer
    Peters Surgical

Manufacturer

Peters Surgical
  • Manufacturer Parent Company (2017)
    Eurazeo SA
  • Source
    NZMMDSA