Events

Recall of SPHINCTER 800 - CONTROL PUMP

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by AMERICAN MEDICAL SYSTEMS CANADA 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
    46657
  • Event Risk Class
    II
  • Event Initiated Date
    2013-06-24
  • 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
    Manufacturing device history record nonconformities: 1. functional test result did not meet the acceptance criteria. 2. functional test result not recorded.

Device

SPHINCTER 800 - CONTROL PUMP
  • Model / Serial
    Model Catalog: 72400098 (Lot serial: >10 SERIAL NOS. CONTACT MFR.); Model Catalog: 72404127 (Lot serial: SN 759728006); Model Catalog: 72404127 (Lot serial: SN 780792002); Model Catalog: 72404127 (Lot serial: SN 786982009); Model Catalog: 72404127 (Lot serial: 759728006); Model Catalog: 72404127 (Lot serial: 765202018); Model Catalog: 72404127 (Lot serial: 786982009); Model Catalog: 72404127 (Lot serial: 780792002); Model Catalog: 72400098 (Lot serial: > 10 numbers contact mfg.); Model Catalog: 72404127 (Lot serial: SN 765202018); Model Catalog: 72400024 (Lot serial: 771029012); Model Catalog: 72400024 (Lot serial: 771029010); Model Catalog: 72400024 (Lot serial: SN 771029010); Model Catalog: 72400024 (Lot serial: SN 771029012)
  • Product Description
    SPHINCTER 800 - CONTROL PUMP
  • Manufacturer
    AMERICAN MEDICAL SYSTEMS CANADA INC.

Manufacturer

AMERICAN MEDICAL SYSTEMS CANADA INC.
  • Manufacturer Address
    GUELPH
  • Source
    HC