Events

Recall of AbbVie Percutaneous Endoscopic Gastronomy and Jejunal tubing kits (AbbVie PEG and AbbVie J)(used for administration of medication Duodopa (Levodopa Carbidopa) Intestinal Gel)AbbVie PEG 15 R

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Abbvie Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2017-RN-00619-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2017-05-17
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00619-1
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    Abbvie has identified the potential for missing components and / or duplicate components in the abbvie peg 15 r and abbvie j intestinal tube 9 fr for peg 15 fr kits. the reported events of missing components have not been associated with any reports to abbvie of related serious injury and it is unlikely for the missing components to pose any significant safety risk.
  • Action
    AbbVie is advising users to inspect the kits using the product’s Instructions for Use, product description section to ensure all components are present before proceeding with implantation. Any missing components are to be reported to AbbVie, including details of the device lot number, and the kit returned to AbbVie. AbbVie will provide replacement kits if there are missing components.

Device

AbbVie Percutaneous Endoscopic Gastronomy and Jejunal tubing kits (AbbVie PEG and AbbVie J)(used ...
  • Model / Serial
    AbbVie Percutaneous Endoscopic Gastronomy and Jejunal tubing kits (AbbVie PEG and AbbVie J)(used for administration of medication Duodopa (Levodopa Carbidopa) Intestinal Gel)AbbVie PEG 15 R Product Code: 62941-001AbbVie J Intestinal Tube 9 FR for PEG 15 FR Product Code: 62943-001All lots may be affected.ARTG Numbers: 223443 and 223444
  • Manufacturer
    Abbvie Pty Ltd

Manufacturer

Abbvie Pty Ltd