Events

Recall of American Surgical Sponges/15252/sponges

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

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
    20013
  • Event Initiated Date
    2016-04-12
  • 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: InterMed Medical Ltd, 71 Apollo Drive, Albany, AUCKLAND 1311
  • Reason
    A failure in the sterile peel pouch has been discovered during a quality control inspection. this failure may result in a small tear in the pouch of the device leading to a potential compromised sterile barrier. a leak in the sterile barrier may allow contamination of the device increasing the risk of infection. after the failure was identified, a comprehensive investigation has shown an occurrence rate of less than 0.01% for the affected lots., the customer was credited & the supplier agreed to have the product destroyed off site.
  • Action
    Product to be destroyed

Device

American Surgical Sponges/15252/sponges
  • Model / Serial
    Model: AS-30-00, AS-30-02, AS-30-03, AS-30-04, AS-30-07 and AS-63-01, Affected:
  • Manufacturer
    American Surgical Sponges

Manufacturer

American Surgical Sponges