Events

Rappel de Jackson-Pratt Perforated and Hemaduct Wound Drainage Systems

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Medline International Two 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-00565-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-05-03
  • 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-00565-1
  • 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
    Medline is recalling specific jackson-pratt perforated and hemaduct wound drainage systems, due to a potential breach of sterility in the packaging. in a small percentage of product (approximately 1.6%), the inner packaging (polybag) is caught in the seal area of the outer tyvek pouch, potentially compromising the sterility of the package contents. use of impacted products could result in an increased risk of infection. to date, the manufacturer has not received any complaints or reports of infection associated with this issue.
  • Action
    Medline is advising customers to remove affected codes/lots from their stock holdings and to also segregate affected units for Medline to collect. Medline will organise pick-up of the affected stock and a credit note will be issued.

Device

Jackson-Pratt Perforated and Hemaduct Wound Drainage Systems
  • Modèle / numéro de série
    Jackson-Pratt Perforated and Hemaduct Wound Drainage SystemsProduct Codes: JP-HUR101, SU130-1308, SU130-1309, SU130-1310, SU130-1311 and SU130-1411 Batch Numbers: 1161468, 1161228, 1161396, 1161413, 1161460, 1161461, 1161230, 1161399, 1161247, 1161251, 1161622, 1161623 and 1161253ARTG Number: 169567
  • Manufacturer
    Medline International Two Australia Pty Ltd

Manufacturer

Medline International Two Australia Pty Ltd