Health product recall

INOmax DS

Last updated

Summary

Product
INOmax DS
Issue
Medical devices - Performance issue
What to do

Contact the manufacturer if you require additional information.

Audience
Healthcare

Affected products

Affected products Lot or serial number Model or catalog number
INOmax DS More than 10 numbers, contact manufacturer. 10007

Issue

The INOmax DS IR delivery system, is not compatible with the upgraded version of the Leoni plus ventilator, manufactured by Lowenstein Medical.  the Leoni plus ventilator was recently upgraded by Lowenstein Medical, with new hardware and software, and the upgraded version cannot be appropriately connected with the INOmax DS IR as instructed in the INOmax DS IR operators manual (om).  the INOmax DS IR om requires warns that the one-way valve must be used.

Recall start date: June 29, 2022

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Anaesthesiology
Companies

Mallinckrodt Manufacturing Llc

6603 Femrite Drive, Madison, Wisconsin, United States, 53718

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-64334