No image published for this recall

No image published for this recall

Datascope Cardiosave Intra-Aortic Balloon Pump (IABP) Safety Disk, Model Number 0202-00-0140 - safety alert

Official notice

29 Mar 2023

Last checked

29 Mar 2023

Critical riskFDA

An official FDA notice concerns Datascope Cardiosave Intra-Aortic Balloon Pump (IABP) Safety Disk, Model Number 0202-00-0140 - safety alert. An official FDA notice concerns Cardiosave Intra-Aortic Balloon Pump (IABP) Safety Disk, Model Number 0202-00-0140. The notice reports a chemical exposure risk. Stop using the product and follow the official notice. Published 2023-03-29. Recall numbers: Z-1278-2023. Check the official notice for the complete list. Published 2023-03-29.

What to do now

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

Units affected

669

Recall number

Z-1278-2023

Official notice

2023-03-29

The hazard

An official FDA notice concerns Cardiosave Intra-Aortic Balloon Pump (IABP) Safety Disk, Model Number 0202-00-0140. The notice reports a chemical exposure risk. Stop using the product and follow the official notice. Published 2023-03-29. Recall numbers: Z-1278-2023. 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.

Event Ids

91652

Recall Numbers

Z-1278-2023

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Affected products

Product 1

Cardiosave Intra-Aortic Balloon Pump (IABP) Safety Disk, Model Number 0202-00-0140

Units affected

669

Risk / hazard

An official FDA notice concerns Cardiosave Intra-Aortic Balloon Pump (IABP) Safety Disk, Model Number 0202-00-0140. The notice reports a chemical exposure risk. Stop using the product and follow the official notice. Published 2023-03-29. Recall numbers: Z-1278-2023. 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 · NJ · Mahwah

Affected area 1

US · United States · NJ · Mahwah

Affected area 2

US · United States

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Datascope. Contact: Datascope Corp..

Source & status

Source

Tier

official

Category

ELECTRONICS

App estimate

critical

Recall details

Recall number

Z-1278-2023

Event id

91652

Units affected

669

Status

active

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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