Events

Rappel de Pilling Knife Handles

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Teleflex Medical Australia Pty 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
    RC-2017-RN-01280-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-10-09
  • 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-2017-RN-01280-1
  • 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
    Teleflex medical has identified that the slot depth of pilling knife handles are out of specification, so blades may not fit on the handles properly. if a blade does not fit properly, the user may struggle to connect the two pieces, causing them to slip and cut their hand. or, if the blade is not securely connected when the product is used in surgery, the blade could dislodge during use and fall into the body cavity. to date, teleflex medical has not received any reports of patient injuries or deaths relating to this issue.
  • Action
    Teleflex is advising customers to quarantine all affected stock and discontinue use. Teleflex will arrange collection of affected product from impacted customers and apply credit to their accounts.

Device

Pilling Knife Handles
  • Modèle / numéro de série
    Pilling Knife HandlesKnife Handle 3 - Straight tip, Straight shaft, 3, 4 7/8" (12.5cm)Knife Handle 3L - Straight tip, Straight shaft, 3L, 8 3/8" (21cm)Knife Handle 3LA - Angled tip, Straight shaft, 3LA, 8 1/8" (20.5cm)Knife Handle 4 - Straight tip, Straight shaft, 4, 5 3/8" (13.5cm)Knife Handle 7 Scalpel - Straight tip, Straight shaft, 7 SCALPEL, 6 3/8" (16.5cm)Multiple Product Codes and Lot NumbersARTG: 94282
  • Manufacturer
    Teleflex Medical Australia Pty Ltd

Manufacturer

Teleflex Medical Australia Pty Ltd