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Inomax ds

Official notice

4 Jul 2022

Last checked

4 Jul 2022

Medium riskHealth Canada

An official Health Canada notice concerns Inomax ds. 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 Published 2022-07-04.

What to do now

Contact the manufacturer if you require additional information.

Recall number

64334

Official notice

2022-07-04

The hazard

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

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Recall Numbers

64334

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Affected products

Product 1

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

Risk / hazard

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

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Mallinckrodt, Inomax Ds.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

64334

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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