Events

Recall of Beckton Dickinson PrepMate™ Vial Cap

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by manufacturer #1479.

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
    19800
  • Event Initiated Date
    2016-02-24
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: Becton Dickinson Ltd, 14B George Bourke Drive, Mt Wellington, Auckland 1060
  • Reason
    The prepmate™ vial cap is the spare lid sold separately to re-seal the bd surepath™ collection vial post processing., some prepmate™ vial caps are cracked on the top and have the potential to cause leakage., the concern with any leakage from the vial after specimen collection is that it could cause irritation or inflammation to skin or mucous membranes since there is an increased risk of chemical or biological exposure. cytological specimens may contain infectious agents. if there is contact due to leakage or splashing (preservative fluid contains 24% ethanol and <1% formaldehyde), it can also cause temporary (non-permanent) vision issues.
  • Action
    Product to be destroyed

Device

Beckton Dickinson PrepMate™ Vial Cap
  • Model / Serial
    Model: 490505, Affected: Lot Nosd: 5029674 5051867 5083935 5117563 5176869 5202623 5198835
  • Manufacturer
    manufacturer #1479

Manufacturer

manufacturer #1479