Reported Sep 25, 2024 · Ongoing
Alaris System PC Unit Model 8015 - a modular infusion pump and monitoring system
CareFusion 303, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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 8015 - a modular infusion pump and monitoring system
- Lot codes and dates
- Model Number8015
- UDI-DI codes
10885403516023108854035152311088540380154910885403801532108854038015181088540351928410885403519215
- Serial Numbers
3,605 of 3,605 codes
164057531640587216376937163896351640592916385933163920291640585916355147163857331635617716358090164056811640536516391644163654071638073616406383163702881634233316406520163404321640648616342209163393601635608916379852164062931636567916343510163400861639405116372192164065471639251916342393163701091637849516380421164062961636635616406474163768141633395916390881163557691640556716405941163807371640621316391082164059881634099916334088163709631640596916406245164063321640622416386484
- Amount recalled
- 125017 device (finished devices and kits)
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
Why it was recalled
Due to affected devices that may have bent female IUI connector and may not be operable and potentially cause delays in the start of the infusion or monitoring.
This product could cause temporary or reversible health problems — stop using it.
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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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