Reported Aug 12, 2020 · Terminated
Alaris System PC Unit Model 8000, 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 System PC Unit Model 8000, 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. **
- US Serial numbers
3,609 of 3,609 codes
232637023263822326385232638736681432326400232640123264022326416232641823264192326423232664723266642326819232682123268342326837232684223268732326882232688323269269300064930008193000839300117930014993001629300163930016493001719300174930017693002849300302930031393003179300333930033493004853669844930053193005329300533930053493005359300538368656040114083696229300093341221024123517412361141236514123981412435041247644124999
- Amount recalled
- 37141
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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