Events

Rappel de Various Tissu-Trans Products

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Precise Medical Supplies.

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-01000-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-08-29
  • 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-01000-1
  • 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
    Results from a visual examination performed on the packaging by the manufacturer shippert medical technologies has revealed that the seal integrity of specific tissu-trans product sterile packages cannot be assured prior to usage without a visual inspection of the seal. to date, shippert has not received any customer complaints or reports of serious injuries and/or deaths due to the lack of sterility.
  • Action
    1. Remove all affected products and store them in a separate area. These products must not come into clinical use. 2. Forward this letter to all staff members that need to be aware of this information letter and the initiated recall. 3. Contact Precise medical supplies customer service for any additional questions regarding return of the products. 4. Replacement product will be issued and sent for returned products.

Device

Various Tissu-Trans Products
  • Modèle / numéro de série
    Various Tissu-Trans ProductsMega Trans 1500Model Number: SH 3-TT-1500Lot Numbers: 61288, 61464Tissu Trans 100ccModel Number: SH 3-TT-FILTRON 100Lot Numbers: 12018, 12109Tissu Trans 1000Model Number: SH 3-TT-FILTRON 1000Lot Numbers: 12004, 61235Tissu Trans 250Model Number: SH 3-TT-FILTRON 250Lot Numbers: 12019, 61286, 61421Filtron 500Model Number: SH 3-TT-FILTRON 500Lot Numbers: 12002, 12046, 61363ARTG Number: 181259
  • Manufacturer
    Precise Medical Supplies

Manufacturer

Precise Medical Supplies
  • Source
    DHTGA