Events

Recall of FLO-RESTER SIZER PACK

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by SYNOVIS SURGICAL INNOVATIONS A DIV. OF SYNOVIS LIFE TECHNOLOGIES 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
    72922
  • Event Risk Class
    II
  • 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
    Le bulbe peut se detacher.

Device

FLO-RESTER SIZER PACK
  • Model / Serial
    Model Catalog: (Lot serial: d) 516001); Model Catalog: (Lot serial: 516003 516002); Model Catalog: (Lot serial: 526067 525588 524943 520805); Model Catalog: (Lot serial: 521864 518549 and 515997); Model Catalog: (Lot serial: 526069 525165 523878 522704)
  • Product Description
    flo-rester sizer pack and sizers
  • Manufacturer
    SYNOVIS SURGICAL INNOVATIONS A DIV. OF SYNOVIS LIFE TECHNOLOGIES INC.

Manufacturer

SYNOVIS SURGICAL INNOVATIONS A DIV. OF SYNOVIS LIFE TECHNOLOGIES INC.
  • Manufacturer Address
    ST-PAUL
  • Source
    HC