Events

Recall of REVOLVE SYSTEM

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

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
    33981
  • Event Risk Class
    II
  • Event Initiated Date
    2017-08-03
  • 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
    This recall has been initiated due to the presence of bacterial endotoxins levels for some revolve units are above the acceptable limits as defined in the standard usp <161> ("medical devices - bacterial endotoxin and pyrogen tests"). the issue was self identified/confirmed on may 4 2017.

Device

REVOLVE SYSTEM
  • Model / Serial
    Model Catalog: RV0004 (Lot serial: >100 NUMBERS CONTACT MFG); Model Catalog: RV0001 (Lot serial: >100 NUMBERS CONTACT MFG); Model Catalog: RV0002 (Lot serial: >100 NUMBERS CONTACT MFG)
  • Product Description
    REVOLVE SYSTEM
  • Manufacturer
    LIFECELL CORPORATION

Manufacturer

LIFECELL CORPORATION