Events

Recall of FLOSEAL Special Applicator Tips

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Baxter Healthcare 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-2018-RN-00670-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-06-07
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00670-1
  • 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
    Baxter healthcare has identified an issue with the use of an incorrect plastic formulation in the manufacture of the blue luer component of the floseal malleable tips. the plastic formulation does not present any toxicity or biocompatibility concerns, but does impact the physical characteristics of the blue luer component. the affected lots of the floseal malleable applicator tip have been associated with the cracking of the luer upon connection with the syringe. since the tip is attached to the syringe outside of the surgical field, it is unlikely that plastic fragments would reach the surgical field. nevertheless, in exceptional cases, detached subvisible particles may be retained in the body and may cause inflammation, or serve as a nidus for bacteria in already contaminated wounds and contribute to allergic reactions. to date, there have been no reports of serious injury associated with this issue.
  • Action
    Baxter is advising customers to locate and return all units of the affected product. Instructions for return can be found on the Customer Letter.

Device

FLOSEAL Special Applicator Tips
  • Model / Serial
    FLOSEAL Special Applicator TipsProduct Code: 1502186Box Lot Number: HA170818 Pouch Lot Numbers: GR338160 (expiry 31 May 2019) and GR338384 (expiry 30 June 2019)ARTG Number: 167776(Baxter Healthcare - Haematological concentrate system applicator, endoscopic)
  • Manufacturer
    Baxter Healthcare Pty Ltd

Manufacturer

Baxter Healthcare Pty Ltd