Events

Recall of Volcano SpinVision Sterile Equipment Cover

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

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
    19957
  • Event Initiated Date
    2016-03-29
  • 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: Device Technologies New Zealand, 47 Arrenway Drive, Albany, AUCKLAND 0632
  • Reason
    Potential that the product may be labelled beyond its expiration date. a number of units at the manufacturing facility may have been shipped in a package with an inventory label containing an expiration date that is one or more months later than the correct expiration dates shown on the product's primary and secondary packaging., the primary packaging includes a label on each pouch containing individually packaged products. the secondary packaging, which is also the shipping box, also contains a label identifying the product by part and lot number., the correct expiration dates located on the labels of the primary and secondary packaging for these products is no earlier than march 2018, so prompt attention to this notice will prevent expired product from mistakenly remaining in inventory. while month and year are listed, the shelf life extends through the last day of the listed month.
  • Action
    Manufacturer to issue advice regarding use

Device

Volcano SpinVision Sterile Equipment Cover
  • Model / Serial
    Model: 891BG-10, Affected:
  • Manufacturer
    Volcano Corp

Manufacturer

Volcano Corp
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    NZMMDSA