Recall of LATEX POWDERED EXAMINATION GLOVES - SIZE FITTED

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by SGMP COMPANY LIMITED.

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
    23523
  • Event Risk Class
    III
  • Event Initiated Date
    2015-05-26
  • Event Country
  • 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
    Revised labelling related to corrective action at distributor level.

Device

  • Model / Serial
    Model Catalog: RSLP 001-80 (Lot serial: n/a); Model Catalog: RSLP 001-75 (Lot serial: n/a); Model Catalog: RSLP 001-70 (Lot serial: n/a); Model Catalog: RSLP 001-65 (Lot serial: n/a); Model Catalog: RSLP 001-60 (Lot serial: n/a); Model Catalog: RSLP 001-55 (Lot serial: n/a); Model Catalog: VSNPF 003-5 (Lot serial: n/a); Model Catalog: VSNPF 003-4 (Lot serial: n/a); Model Catalog: VSNPF 003-3/4 (Lot serial: n/a); Model Catalog: VSNPF 003-3 (Lot serial: n/a); Model Catalog: VSNPF 003-2 (Lot serial: n/a); Model Catalog: VSNPF 003-1 (Lot serial: n/a); Model Catalog: RSNPF 003-5 (Lot serial: n/a); Model Catalog: RSNPF 003-4 (Lot serial: n/a); Model Catalog: RSNPF 003-3/4 (Lot serial: n/a); Model Catalog: RSNPF 003-2 (Lot serial: n/a); Model Catalog: RSNPF 003-1 (Lot serial: n/a); Model Catalog: VSLPF 002-90 (Lot serial: n/a); Model Catalog: VSLPF 002-85 (Lot serial: n/a); Model Catalog: VSLPF 002-80 (Lot serial: n/a); Model Catalog: VSLPF 002-75 (Lot serial: n/a); Model Catalog: VSLPF 002-70 (Lot serial: n/a); Mo
  • Product Description
    Latex Powdered examination gloves - size fitted
  • Manufacturer

Manufacturer