Events

Rappel de Various Disposable Catheter Mounts Straight Swivel Swivel Elbow Straight Adaptors Elbow Double Swivel Elbow

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-01168-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-09-11
  • 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-01168-1
  • 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
    During a regular qa inspection, parker healthcare noticed an irregularity in the expandable tubing of specific tube/mask breathing circuit single-use connectors (disposable catheter mounts). to date, no injury or illness has been reported.
  • Action
    1. Complete and return the supplied acknowledgement form. If any of the affected products have been transferred from your facility to another, immediately inform other supplied facilities of this Recall. 2. Isolate the unit(s) from the affected Batch(es)/Lot(s) and contact Parker Healthcare Customer Service Team on 1300 361 201 or via email sales@parkerhealth.com.au to arrange the return of stock and the supply of replacement stock. Returned stock will be replaced with unaffected batches at no cost.

Device

Various Disposable Catheter Mounts Straight Swivel Swivel Elbow Straight Adaptors Elbow Double Sw...
  • Modèle / numéro de série
    Various Disposable Catheter MountsStraight SwivelSwivel ElbowStraight AdaptorsElbowDouble Swivel ElbowMultiple Product Names, Part Numbers and Batch NumbersARTG Number: 188096
  • Manufacturer
    Swirl Technologies Pty Ltd T/A Parker Healthcare

Manufacturer

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