Events

Recall of CENTRAL LINE INSERTION PACKS

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by CARDINAL HEALTH CANADA INC..

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
    30009
  • Event Risk Class
    II
  • Event Initiated Date
    2017-07-31
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Extra notes in the data
  • Reason
    Bd has initiated an urgent product recall of the component 306553 the bd posiflusht saline flush syringe 10ml lots 4128353 3046276 and 3024261 since some unit packages may exhibit open seals which impacts package integrity and potentially product sterility. the syringes are found in these cardinal health presource kits.

Device

CENTRAL LINE INSERTION PACKS
  • Model / Serial
    Model Catalog: SAN30CLHMA (Lot serial: 155246); Model Catalog: SAN30CLHMA (Lot serial: 150538); Model Catalog: SAN30CCSNA (Lot serial: 160621); Model Catalog: SAN30PIGRB (Lot serial: 164007); Model Catalog: SCV30EVMGB (Lot serial: 150796); Model Catalog: SAN30PIGRB (Lot serial: 155874); Model Catalog: SAN30PLRGC (Lot serial: 212412); Model Catalog: SAN30PLRGB (Lot serial: 212412); Model Catalog: SAN30PCSNB (Lot serial: 212412); Model Catalog: SAN30PLRGC (Lot serial: 165115); Model Catalog: SAN30PLRGB (Lot serial: 165115); Model Catalog: SAN30PCSNB (Lot serial: 165115); Model Catalog: SAN30PLRGC (Lot serial: 158842); Model Catalog: SAN30PLRGB (Lot serial: 158842); Model Catalog: SAN30PCSNB (Lot serial: 158842); Model Catalog: SAN30PCSNB (Lot serial: 153953); Model Catalog: SAN30PLRGB (Lot serial: 153953); Model Catalog: SAN30PLRGC (Lot serial: 153953); Model Catalog: SAN30PCSNB (Lot serial: 159524); Model Catalog: SAN30PLRGC (Lot serial: 159524); Model Catalog: SAN30PLRGB (Lot serial: 159524); Model Catalog:
  • Product Description
    STR CENTRAL LINE INSERTION KIT
  • Manufacturer
    CARDINAL HEALTH CANADA INC.

Manufacturer

CARDINAL HEALTH CANADA INC.
  • Manufacturer Address
    MISSISSAUGA
  • Manufacturer Parent Company (2017)
    Cardinal Health
  • Source
    HC