Events

translation missing: en.activerecord.attributes.event.titles.recall_field_safety_notice

According to Saudi Food & Drug Authority, this translation missing: en.activerecord.attributes.event.types.recall_field_safety_notice involved a device in Saudi Arabia that was produced by Hospira Inc.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Recall / Field Safety Notice
  • Event ID
    mdprc 051 09 13 000
  • Event Initiated Date
    2013-09-10
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=4356
  • Notes / Alerts
    Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug 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 Saudi Arabia.
  • Extra notes in the data
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Reason
    Hospira has become aware that customers may be inappropriately using incorrectly sized receptal liners with receptal canisters (e.G. 1.5l liner, 2l liner or 3l liner with a 1l canister). it is possible that if the incorrectly sized liners are used with different size canisters, the lid may not fit and the vacuum/suction will not be sufficient and/or consistent. to date, hospira has received reports associated with this practice, including one that resulted in a serious injury and one that resulted in a death, and recommends against this practice.

Device

Receptal System Liners and Canisters
  • Model / Serial
    List Number : ( Product Description ); 77042, 43449, 43423-8911, 43445-6111, 43503-6118 : ( Abbott canister, 1L canister, 1.5L canister, 2L canister, 3L canister )(respectively). See attached for full list
  • Product Description
    It is a closed disposable suction system that is used to remove waste, blood or other fluids during surgeries or to clear patient airways, throat or wounds to allow treatment
  • Manufacturer
    Hospira Inc

Manufacturer

Hospira Inc
  • Manufacturer Parent Company (2017)
    Pfizer
  • Manufacturers representative
    AL-KAMAL Import, Riyadh, (01) 2181122
  • Source
    SFDA