Events

Recall of Various Kits containing Anticoagulant Citrate Dextrose Solution, Solution A (ACDA) 30mL Vials (Supplied in apheresis and surgical procedure kits) Affected kits:BIOCUE STD KIT ACD-A W/BD, SINGLE KIT W/BLOOD DRAW, GPS BONE BIOLOGICS KIT 20mL + S.TUBE, 2MARROWSTIM CALCIBON KIT 20mL, MARROWBIOCUE CALCIBON KIT 20mL

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Zimmer 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-2016-RN-01011-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-08-01
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01011-1
  • 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
    Zimmer biomet has initiated this action following an investigation which identified a defect with the acda 30 ml vial known as a split finish that could compromise product sterility. split finishes occur during the glass bottle manufacturing process. the data shows that the risk of a sterility breach is rare <1% and the risk of injury to patients is remote <0.1%. use may result in an infection. there have been no reported complaints to date.
  • Action
    Zimmer Biomet is advising users inspect and quarantine affected stock for return. This action has been closed-out on 02/03/2017.

Device

Various Kits containing Anticoagulant Citrate Dextrose Solution, Solution A (ACDA) 30mL Vials (Su...
  • Model / Serial
    Various Kits containing Anticoagulant Citrate Dextrose Solution, Solution A (ACDA) 30mL Vials (Supplied in apheresis and surgical procedure kits)Affected kits:BIOCUE STD KIT ACD-A W/BDProduct Number: 800-0613A GPS3 SINGLE KIT W/BLOOD DRAWProduct Number: 800-0675A GPS BONE BIOLOGICS KIT 20mL + S.TUBEProduct Number: TCP20GPSS.2MARROWSTIM CALCIBON KIT 20mLProduct Number: TCP20MARROWBIOCUE CALCIBON KIT 20mLProduct Number: TCP20BIOCUE ARTG #: 183209, 100053, 127024
  • Manufacturer
    Zimmer Pty Ltd

Manufacturer

Zimmer Pty Ltd
  • Manufacturer Parent Company (2017)
    Zimmer Biomet Holdings
  • Manufacturer comment
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    DHTGA