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Fresenius Kabi LVP software of the Ivenix Infusion System (IIS); LVP-SW-0004 - safety alert

Official notice

20 Mar 2024

Last checked

20 Mar 2024

Critical riskFDA

An official FDA notice concerns Fresenius Kabi LVP software of the Ivenix Infusion System (IIS); LVP-SW-0004 - safety alert. An official FDA notice concerns LVP software of the Ivenix Infusion System (IIS); LVP-SW-0004. The notice reports a chemical exposure risk. Stop using the product and follow the official notice. Published 2024-03-20. Recall numbers: Z-1283-2024. Check the official notice for the complete list. Published 2024-03-20.

What to do now

The source does not provide specific consumer instructions. Follow the official FDA notice for next steps.

Units affected

6

Recall number

Z-1283-2024

Official notice

2024-03-20

The hazard

An official FDA notice concerns LVP software of the Ivenix Infusion System (IIS); LVP-SW-0004. The notice reports a chemical exposure risk. Stop using the product and follow the official notice. Published 2024-03-20. Recall numbers: Z-1283-2024. Check the official notice for the complete list.

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.

Other

UDI-DI 00811505030122

Event Ids

93968

Recall Numbers

Z-1283-2024

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Affected products

Product 1

LVP software of the Ivenix Infusion System (IIS); LVP-SW-0004

Units affected

6

Risk / hazard

An official FDA notice concerns LVP software of the Ivenix Infusion System (IIS); LVP-SW-0004. The notice reports a chemical exposure risk. Stop using the product and follow the official notice. Published 2024-03-20. Recall numbers: Z-1283-2024. Check the official notice for the complete list.

Where it was sold

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

Location 1

US · United States · MA · North Andover

Affected area 1

US · United States · MA · North Andover

Affected area 2

US · United States

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Fresenius Kabi. Contact: Fresenius Kabi USA, LLC.

Source & status

Source

Tier

official

Category

ELECTRONICS

App estimate

critical

Recall details

Recall number

Z-1283-2024

Event id

93968

Units affected

6

Status

terminated

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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