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 Kimal plc.

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 026 05 15 001
  • Event Initiated Date
    2015-06-03
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=7732
  • 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, MHRA
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Reason
    The light glove may contain splits or holes or be torn.

Device

Devon Light Glove included in various Kimal Procedure Packs
  • Model / Serial
    Product Description: PSCC PAEDIATRIC ANGIO PACK Product Code: SA-K20380 Product Description: PSCC PAEDIATRIC ANGIO PACK Product Code: SA-K20380/P1 Product Description: KFMC PAEDIATRIC PACK Product Code: SA-K41949/P1 Product Description: KKNGH CARDIOLOGY PACING PACK Product Code: SA-K42117 Product Description: KKNGH REVEAL PACK Product Code: SA-K42118 Product Description: PSCC PAEDIATRIC ANGIO PACK Product Code: SA-K43714 Product Description: CAESARIAN-SECTION PACK PSCC Product Code: SPR/9911/45035 Product Description: KFNGH PAEDIATRIC CATH LAB PACK Product Code: SPR/9964/41494 Product Description: KFNGH ADULT CATH LAB PACK Product Code: SPR/9964/41495 Product Description: PSCC PAEDIATRIC ANGIO PACK Product Code: SPR/9964/42508 Product Description: KKUH PAEDIATRIC ANGIO PACK Product Code: SPR/9964/42865 Product Description: PSCC PAEDIATRIC ANGIO PACK Product Code: SPR/9964/43714 Product Description: PSCC PAEDIATRIC ANGIO PACK Product Code: SPR/9964/45033 Lot Numbers : Please see attached ..................... MHRA update code Multiple products and Lot numbers of the affected device are provided in the attached FSN.
  • Product Description
    This product is a disposable cover used in operating rooms
  • Manufacturer
    Kimal plc

Manufacturer

Kimal plc