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5008X Standard HD Pre-Flush Standard Blood Tubing Set Part Number 03-5110-6

Official notice

9 Sept 2026

Last checked

22 Sept 2026

MediumFDA

An official FDA notice concerns 5008X Standard HD Pre-Flush Standard Blood Tubing Set Part Number 03-5110-6. The notice reports a chemical exposure risk. Stop using the product and follow the official notice. Published 2026-09-09. Recall numbers: Z-3084-2026. Check the official notice for the complete list.

What to do now

Instructions for consumers are available in the official FDA notice.

Units affected

120

Recall number

Z-3084-2026

Official notice

2026-09-09

The hazard

Chemical exposure risk

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 00840861102556

Event Ids

99556

Recall Numbers

Z-3084-2026

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Affected products

Product 1

5008X Standard HD Pre-Flush Standard Blood Tubing Set Part Number 03-5110-6

Units affected

120

Risk / hazard

Chemical exposure risk

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

Affected area 1

US · United States

Affected area 2

LT · Lithuania

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Fresenius Medical Care Renal Therapies. Contact: Fresenius Medical Care Renal Therapies Group, LLC.

Source & status

Source

Tier

official

Category

ELECTRONICS

Classification

Class II

App estimate

medium

Recall details

Recall number

Z-3084-2026

Event id

99556

Units affected

120

Status

active

Classification

Class 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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