Events

Rappel de Various Disposable Catheter Mounts

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Swirl Technologies Pty Ltd T/A Parker 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-2017-RN-01268-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2017-10-04
  • 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-01268-1
  • 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
    Parker healthcare are recalling the affected stock due to a potential obstruction within the swivel elbow adaptor. if component is obstructed, it would restrict the gas flow to the patient and may lead to serious health consequences. two incidents of faulty catheter mounts have been reported. however, to date, no injuries have occurred.
  • Action
    Parker Healthcare are advising users to inspect stock and quarantine any affected units. Affected stock can be returned to Parker for replacement with unaffected product.

Device

Various Disposable Catheter Mounts
  • Modèle / numéro de série
    Various Disposable Catheter MountsDisposable Catheter Mount, Dble Swvl Elbow w Suction Port & Adaptor 15MPart Number: 6000-40(D)Disposable Catheter Mount Dble Swvl Elbw w Suction Port & Adaptor 15M SterilePart Number: 6000-40(D)/SDisposable Catheter Mount, Dble Swvl Elbow w Suction Port & Adaptor 22FPart Number: 6000-41(D)Double Swvl Elbw w Suction Port and Cap 15mmM to 22mmM/15mmF Sterile PPPart Number: PH71522/SMultiple Batch NumbersARTG Number: 188096
  • Manufacturer
    Swirl Technologies Pty Ltd T/A Parker Healthcare

Manufacturer

Swirl Technologies Pty Ltd T/A Parker Healthcare
  • Source
    DHTGA