Events

Recall of H.LEE SAFESHEATH SUBCLAVIAN INTRODUCER SYSTEM

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

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
    50440
  • Event Risk Class
    II
  • Event Initiated Date
    2011-05-06
  • 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.
  • Extra notes in the data
  • Reason
    Thomas medical products has become aware that in some instances the pouch seal that maintains the sterility of the product may be weak or open and compromise the sterile barrier.

Device

H.LEE SAFESHEATH SUBCLAVIAN INTRODUCER SYSTEM
  • Model / Serial
    Model Catalog: M209535-008 (Lot serial: S32924); Model Catalog: M209535-013 (Lot serial: S32924); Model Catalog: M209535-015 (Lot serial: S32924); Model Catalog: HLS-1009 (Lot serial: S32924); Model Catalog: HLS-2507 (Lot serial: S32924); Model Catalog: HLS-2509 (Lot serial: S32924); Model Catalog: HLS-1007 (Lot serial: S32924); Model Catalog: HLS-1009.5 (Lot serial: S32924); Model Catalog: HLS-1006 (Lot serial: S32924); Model Catalog: M209535-008 (Lot serial: S32931); Model Catalog: M209535-013 (Lot serial: S32931); Model Catalog: M209535-015 (Lot serial: S32931); Model Catalog: HLS-1009 (Lot serial: S32931); Model Catalog: HLS-2507 (Lot serial: S32931); Model Catalog: HLS-2509 (Lot serial: S32931); Model Catalog: HLS-1007 (Lot serial: S32931); Model Catalog: HLS-1009.5 (Lot serial: S32931); Model Catalog: HLS-1006 (Lot serial: S32931); Model Catalog: M209535-008 (Lot serial: S33309); Model Catalog: M209535-013 (Lot serial: S33309); Model Catalog: M209535-015 (Lot serial: S33309); Model Catalog: HLS-1009 (L
  • Product Description
    SAFESHEATH VASCULAR ACCESS INTRODUCER
  • Manufacturer
    LIVANOVA CANADA CORP.

Manufacturer

LIVANOVA CANADA CORP.
  • Manufacturer Address
    MARKHAM
  • Manufacturer Parent Company (2017)
    LivaNova PLC
  • Source
    HC