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Icu Medical - safety alert

Official notice

22 Sept 2021

Last checked

22 Sept 2021

Critical riskFDA

An official FDA notice concerns Icu Medical - safety alert. An official FDA notice concerns Icu Medical. The notice reports a serious safety risk. Follow the official notice for consumer instructions. Published 2021-09-22. Lots: 4989094. Recall numbers: D-0805-2021. Check the official notice for the complete list. Published 2021-09-22.

What to do now

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

Units affected

2,112

Recall number

D-0805-2021

Official notice

2021-09-22

The hazard

An official FDA notice concerns Icu Medical. The notice reports a serious safety risk. Follow the official notice for consumer instructions. Published 2021-09-22. Lots: 4989094. Recall numbers: D-0805-2021. 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.

Lots

4989094

Event Ids

88620

Recall Numbers

D-0805-2021

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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 · IL · Lake Forest

Affected area 1

US · United States · IL · Lake Forest

Affected area 2

US · United States

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Icu Medical. Contact: ICU Medical Inc.

Source & status

Source

Tier

official

Category

HEALTH

App estimate

critical

Recall details

Recall number

D-0805-2021

Event id

88620

Units affected

2,112

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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