Events

Recall of PLATELET CONCENTRATE INFUSION SET

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by HOSPIRA HEALTHCARE CORPORATION.

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
    17795
  • Event Risk Class
    II
  • Event Initiated Date
    2013-12-06
  • 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.
    ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
  • Extra notes in the data
  • Reason
    There is a potential for certain blood sets to puncture the outer wall of non-iso compliant blood bags. the iso piercing pin tip is sharper and longer than the port on the blood bag which is very short in certain non-iso blood bags and results in the leakage from the bag.

Device

PLATELET CONCENTRATE INFUSION SET
  • Model / Serial
    Model Catalog: 14237001 (Lot serial: 112274w); Model Catalog: 14210001 (Lot serial: 053835H); Model Catalog: 14212001 (Lot serial: >10 lot numbers contact mfg)
  • Product Description
    Platelet Concentrate Infusion Set
  • Manufacturer
    HOSPIRA HEALTHCARE CORPORATION

Manufacturer

HOSPIRA HEALTHCARE CORPORATION
  • Manufacturer Address
    SAINT-LAURENT
  • Manufacturer Parent Company (2017)
    Pfizer
  • Source
    HC