Reported Aug 12, 2020 · Terminated
Alaris SpO2 Module Model 8210 and Model 8220, a modular infusion pump and monitoring system
CareFusion 303, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: CareFusion 303, Inc. · 10020 Pacific Mesa Blvd · San Diego, CA · 92121-4386
Is this the product you have?
- Alaris SpO2 Module Model 8210 and Model 8220, a modular infusion pump and monitoring system
- Lot codes and dates
- During cleaning, updated cleaning instructions and IUI covers must be used for all serial numbers.
- Amount recalled
- 7854
This recall covers 11 products
The agency filed one notice per product. You are reading one of them; the other 10 are below.
Where it was sold
Why it was recalled
Stop using this product now
Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption of communication or power between PC Unit and modules, which may result in an infusion that stops with a CHANNEL DISCONNECTED message, and an audio/visual alarm on the PC Unit and an interruption of therapy or monitoring.
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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