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Icu Medical ChemoLock Bag Spike, 01 units REF: CL-10-10 - safety alert

Official notice

5 Nov 2025

MediumFDA

An official FDA notice concerns ChemoLock Bag Spike, 01 units REF: CL-10-10. The notice reports a health risk requiring medical assessment. Stop using the product and follow the official notice. Published 2025-11-05. Lots: 14397202. Recall numbers: Z-0328-2026. Check the official notice for the complete list.

What to do now

Instructions for consumers are available in the official FDA notice.

Units affected

875

Recall number

Z-0328-2026

Official notice

2025-11-05

The hazard

Health risk requiring medical assessment

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

14397202

Event Ids

97583

Recall Numbers

Z-0328-2026

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Affected products

Product 1

ChemoLock Bag Spike, 01 units REF: CL-10-10

Units affected

875

Risk / hazard

Health risk requiring medical assessment

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

CA · Canada

Affected area 3

FR · France

Affected area 4

JP · Japan

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Icu Medical. Contact: ICU Medical, Inc..

Source & status

Source

Tier

official

Category

ELECTRONICS

Classification

Class II

App estimate

medium

Recall details

Recall number

Z-0328-2026

Event id

97583

Units affected

875

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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