Events

Rappel de Safil Sutures Safil Violet 1 (4) 70cm HR26 Safil Violet 4/0 (1,5) 70cm HR22 Safil Violet Undyed 4/0 (1,5) 70cm, DS24 Safil Violet Undyed 2/0 (3) 70cm HR26 Safil Violet 3/0 (2) 70cm, HR22 Safil Violet 2 (5) 70cm HR 37S Safil Violet 2 (5) 70cm HR37S

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par B Braun 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-2018-RN-00737-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-06-20
  • 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-2018-RN-00737-1
  • 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
    B. braun has been identified that some of the items in specific batches have damaged packaging which may affect the sterility of the products. no specific monitoring of patients is recommended at this time.To date, there have been no reports of any adverse patient outcome which could be associated with this potential sterility issue.
  • Action
    B. Braun is requesting customers: 1. Identify, quarantine and return affected devices; 2. Do not use affected devices anymore; 3. Patients with affected devices in use should be monitored carefully; 4. Inform the responsible personnel in the relevant facilities; and 5. Confirm receipt of the correspondence as per the instructions given in the Customer Letter.

Device

Safil Sutures Safil Violet 1 (4) 70cm HR26 Safil Violet 4/0 (1,5) 70cm HR22 Safil Violet Undyed 4...
  • Modèle / numéro de série
    Safil Sutures Safil Violet 1 (4) 70cm HR26Safil Violet 4/0 (1,5) 70cm HR22Safil Violet Undyed 4/0 (1,5) 70cm, DS24Safil Violet Undyed 2/0 (3) 70cm HR26Safil Violet 3/0 (2) 70cm, HR22Safil Violet 2 (5) 70cm HR 37SSafil Violet 2 (5) 70cm HR37SMultiple Item Codes and Batch NumbersARTG Number: 222738
  • Manufacturer
    B Braun Australia Pty Ltd

Manufacturer

B Braun Australia Pty Ltd