Events

Rappel de SANDEL Weighted Safety Scalpels

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Ansell Ltd T/A Ansell Healthcare.

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
    RC-2015-RN-00167-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-02-26
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00167-1
  • Notes / Alertes
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notes supplémentaires dans les données
  • Cause
    In november of 2013 ansell limited undertook a recall of a number of specific batches of some of the product codes for the above product. tga recall rc-2013-rn-01152-1 refers. this recall was closed out by the tga on 13 february 2015.As an interim corrective action, both the overseas manufacturer and ansell limited in california implemented a 100% visual inspection of all product prior to shipping from our warehouse to prevent recurrence of the problem of the safety shield moving and the blade tip being exposed.Subsequently, one customer complaint has been received of a user receiving an injury from an exposed blade tip while picking up the scalpel from the dispenser pack. this was a scalpel not originating from any identified lot of product from the original recall.Upon inspecting warehouse stock, we have further identified a small number of scalpels where the blade tip has become exposed. these were all found before the product was shipped to distributors or customers.
  • Action
    Ansell is requesting users to quarantine affected lots and return to Ansell for replacement or credit. This action has been closed-out on 1/06/2016.

Device

SANDEL Weighted Safety Scalpels
  • Modèle / numéro de série
    SANDEL Weighted Safety ScalpelsCatalogue numbers: 2210-N, 2211-N, 2215-N, 2220-N, 2210-L, 2211-L & 2215-LARTG number: 196914
  • Manufacturer
    Ansell Ltd T/A Ansell Healthcare

Manufacturer

Ansell Ltd T/A Ansell Healthcare