Events

Recall of RUMI ARCH REUSABLE UTERINE MANIPULATOR HANDLE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by SUPERIOR MEDICAL 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
    99073
  • Event Risk Class
    II
  • Event Initiated Date
    2012-12-07
  • 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
    Excessive pressure exerted on the uterine tip when attached to the arch may under certain circumastances cause the internal steel rod of the tip to protrude through the cleaning hole on the shaft of the handle.

Device

RUMI ARCH REUSABLE UTERINE MANIPULATOR HANDLE
  • Model / Serial
    Model Catalog: UMH700 (Lot serial: >1000 numbers contact mfg); Model Catalog: UMH700 (Lot serial: 10683); Model Catalog: UMH700 (Lot serial: 0711039); Model Catalog: UMH700 (Lot serial: 0711017); Model Catalog: UMH700 (Lot serial: 10336); Model Catalog: UMH750 (Lot serial: 1112036); Model Catalog: UMH750 (Lot serial: 1112035); Model Catalog: UMH750 (Lot serial: 11110061); Model Catalog: UMH750 (Lot serial: >1000 numbers contact mfg); Model Catalog: UMH750 (Lot serial: 11110042); Model Catalog: UMH750 (Lot serial: 11110037); Model Catalog: UMH750 (Lot serial: 11110032); Model Catalog: UMH750 (Lot serial: 11110046)
  • Product Description
    RUMI Arch Reusable Uterine Manipulator Handle
  • Manufacturer
    SUPERIOR MEDICAL LIMITED

Manufacturer

SUPERIOR MEDICAL LIMITED