Events

Recall of CBCII AMBULATING BULB (PK10), 1/8 TROCAR W/DRAIN (PK10), 1/4 TROCAR W/DRAIN (PK10)CBCII AMBULATING BULB (PK10)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Stryker Australia 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-2015-RN-00284-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-03-30
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00284-1
  • 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
    The manufacturer have identified that the boxes used to ship the products were too small for the number of products (10 units) packaged within the box. the units packed into the shipper experienced bending and folding of the pouches. this can increase the risk of breaching the outer pouch. note that only a breach in the exterior pouch was detected – the interior pouch was not breached. a breach would have to develop in both pouches before the product would become unsterile.
  • Action
    Stryker is requesting their customer to discontinue use and quarantine the affected product. A Stryker Representative will organise for the removal of any affected units found and a credit will be given for these items.

Device

CBCII AMBULATING BULB (PK10), 1/8 TROCAR W/DRAIN (PK10), 1/4 TROCAR W/DRAIN (PK10)CBCII AMBULATIN...
  • Model / Serial
    CBCII AMBULATING BULB (PK10), 1/8 TROCAR W/DRAIN (PK10), 1/4 TROCAR W/DRAIN (PK10)CBCII AMBULATING BULB (PK10)Catalogue Number: 0225028852Lot Numbers: 10337012, 102810121/8 TROCAR W/DRAIN (PK10)Catalogue Number: 0215018000Lot Numbers: 13191012, 11088012,11125012, 112040121/4 TROCAR W/DRAIN (PK10)Catalogue Number: 0215019000Lot Number: 12235012ARTG Numbers: 140544, 233315
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

Stryker Australia Pty Ltd
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    DHTGA