Events

Rappel de BSN Propax Obstetric/Gynae packs

Selon New Zealand Medicines and Medical Devices Safety Authority, ce/cet/cette rappel concerne un dispositif en/au/aux/à New Zealand qui a été fabriqué par BSN Medical Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    21061
  • Date de mise en oeuvre de l'événement
    2017-01-31
  • Pays de l'événement
    New Zealand
  • Source de l'événement
    NZMMDSA
  • URL de la source de l'événement
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Recalling Organisation: BSN Medical Ltd, 621 Rosebank Rd, Avondale, AUCKLAND
  • Cause
    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
  • Modèle / numéro de série
    Model: 056 106 046 066 086 096 106 116 017, Affected:
  • Manufacturer
    BSN Medical Ltd

Manufacturer

BSN Medical Ltd