Events

Rappel de Various Kits containing Anticoagulant Citrate Dextrose Solution, Solution A (ACDA) 30mL Vials (Supplied in apheresis and surgical procedure kits) Affected kits:BIOCUE STD KIT ACD-A W/BD, SINGLE KIT W/BLOOD DRAW, GPS BONE BIOLOGICS KIT 20mL + S.TUBE, 2MARROWSTIM CALCIBON KIT 20mL, MARROWBIOCUE CALCIBON KIT 20mL

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Zimmer 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-2016-RN-01011-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-08-01
  • 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-2016-RN-01011-1
  • 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
    Zimmer biomet has initiated this action following an investigation which identified a defect with the acda 30 ml vial known as a split finish that could compromise product sterility. split finishes occur during the glass bottle manufacturing process. the data shows that the risk of a sterility breach is rare <1% and the risk of injury to patients is remote <0.1%. use may result in an infection. there have been no reported complaints to date.
  • Action
    Zimmer Biomet is advising users inspect and quarantine affected stock for return. This action has been closed-out on 02/03/2017.

Device

Various Kits containing Anticoagulant Citrate Dextrose Solution, Solution A (ACDA) 30mL Vials (Su...
  • Modèle / numéro de série
    Various Kits containing Anticoagulant Citrate Dextrose Solution, Solution A (ACDA) 30mL Vials (Supplied in apheresis and surgical procedure kits)Affected kits:BIOCUE STD KIT ACD-A W/BDProduct Number: 800-0613A GPS3 SINGLE KIT W/BLOOD DRAWProduct Number: 800-0675A GPS BONE BIOLOGICS KIT 20mL + S.TUBEProduct Number: TCP20GPSS.2MARROWSTIM CALCIBON KIT 20mLProduct Number: TCP20MARROWBIOCUE CALCIBON KIT 20mLProduct Number: TCP20BIOCUE ARTG #: 183209, 100053, 127024
  • Manufacturer
    Zimmer Pty Ltd

Manufacturer

Zimmer Pty Ltd
  • Société-mère du fabricant (2017)
    Zimmer Biomet Holdings
  • Commentaire du fabricant
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    DHTGA