No image published for this recall

No image published for this recall

Fresenius Medical Care 190904 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part, Model Number: F40015481 Rev A - safety alert

Official notice

17 Jul 2024

Last checked

17 Jul 2024

Medium riskFDA

An official FDA notice concerns Fresenius Medical Care 190904 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part, Model Number: F40015481 Rev A - safety alert. An official FDA notice concerns 190904 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part, Model Number: F40015481 Rev A. The notice reports a health risk requiring medical assessment. Stop using the product and follow the official notice. Published 2024-07-17. Models: 190904. Recall numbers: Z-2340-2024. Check the official notice for the complete list. Published 2024-07-17.

What to do now

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

Units affected

372

Recall number

Z-2340-2024

Official notice

2024-07-17

The hazard

An official FDA notice concerns 190904 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part, Model Number: F40015481 Rev A. The notice reports a health risk requiring medical assessment. Stop using the product and follow the official notice. Published 2024-07-17. Models: 190904. Recall numbers: Z-2340-2024. 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.

Skus

190904

Event Ids

94775

Model Numbers

190904

Recall Numbers

Z-2340-2024

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Affected products

Product 1

190904 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part, Model Number: F40015481 Rev A

Units affected

372

Risk / hazard

An official FDA notice concerns 190904 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part, Model Number: F40015481 Rev A. The notice reports a health risk requiring medical assessment. Stop using the product and follow the official notice. Published 2024-07-17. Models: 190904. Recall numbers: Z-2340-2024. 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 · Waltham

Affected area 1

US · United States · MA · Waltham

Affected area 2

US · United States

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Fresenius Medical Care. Contact: Fresenius Medical Care Holdings, Inc..

Source & status

Source

Tier

official

Category

ELECTRONICS

App estimate

medium

Recall details

Recall number

Z-2340-2024

Event id

94775

Units affected

372

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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