Events

Recall of Infusion - Swiss - Connectors Adaptors

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by CareFusion Switzerland 317 Sarl.

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
    22024
  • Event Initiated Date
    2017-09-26
  • 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: CareFusion New Zealand 313 Limited, Unit 14, 13 Highbrook Drive, East Tamaki, AUCKLAND
  • Reason
    The investigation results indicate that the pinholes in the blister pouch is related to the secondary packaging process where the blister packs are placed in dispensers and in shelf boxes. the device has sharp points and during the packing of the carton, accidental pressure was applied, causing the blister pouches to press against each other.
  • Action
    Product to be returned to supplier

Device

Infusion - Swiss - Connectors Adaptors
  • Model / Serial
    Model: , Affected: 11 gauge 9391-0200 Lot numbers 1470303001, 1470304601, 1470306301,1470311301, 1470314801, 1570317701,1570317702, 1570317704, 1570322001,1470306602
  • Manufacturer
    CareFusion Switzerland 317 Sarl

Manufacturer

CareFusion Switzerland 317 Sarl