Events

Recall of BSN Propax Obstetric/Gynae packs

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

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
    21061
  • Event Initiated Date
    2017-01-31
  • 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: BSN Medical Ltd, 621 Rosebank Rd, Avondale, AUCKLAND
  • Reason
    Sterile consumable devices are being delivered with foreign particles found in a number of packets from two batches, appearing to be dust, lint , cardboard. another packet was found today with at least three foreign bodies in that it appear and feel (through the packing only ) to be metal shards/ shavings. two different batches are involved. this problem has the potential to cause injury or infection in patient. if the consumables are used in the manner they are meant to be, in the treatment of wounds following surgery. manufacturer advised medsafe would be informed today (26 jan 2017), 03februiary 2017 source of the metal fragment is the raw material, i.E. the maternity pad. company has then drawn the correlation that this raw material is used in some of bsn's sterilised customised procedure packs (cpps) and therefore are extending the product alert to include the cpps in its scope.
  • Action
    Manufacturer to issue advice regarding use

Device

BSN Propax Obstetric/Gynae packs
  • Model / Serial
    Model: 056 106 046 066 086 096 106 116 017, Affected:
  • Manufacturer
    BSN Medical Ltd

Manufacturer

BSN Medical Ltd