Reported Jul 24, 2024 · Ongoing
BD Pyxis
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?
BD Pyxis
8 of 8 products
| Model / number | Product as published |
|---|---|
323 | MedStation ES (Main) |
352 | MedStation ES Tower |
327 | Anesthesia Station ES |
1116-00 | CII Safe ES |
107-254-01 | CII Safe ES, Desktop PC, Wired Scanner |
107-255-01 | CII Safe ES, Desktop PC, Wireless Scanner |
107-256-01 | CII Safe ES, Desktop PC, Wired Scanner 1.7.3 |
107-257-01 | CII Safe ES, Desktop PC, Wireless Scanner 1.7.3 |
- Lot codes and dates
- REF/UDI-DI
323/10885403512667352/10885403512674327/108854034778361116-00/10885403512605
- Software VersionES 1.7
- x Serial Numbers
319 of 319 codes
135347451622073816446299164463031644630216247443162474401596299016417275164462971644629616242783162342661542509316446295164462911624278416417277156441761401933216212329162215171639585716059358162541911531946615154945151536021621532515154942149590511639585516395853162153131636189314826969148269721482697114826973142328561624134213877154151488811514886015148880151488821585460115148883151488651514888515160417162129611585459515148859151488621514886115148863151488661514886815854596
- REF/UDI-DI
- Amount recalled
- 326
Where it was sold
Why it was recalled
If automated dispensing cabinets have specific software versions, and Component Manager was configured to "installed mode", and software patch KB 5033688 was installed in the production environment, then this will will lead to an error that prevents the user from accessing the dispensing software application, which may delay accessing medication.
This product could cause temporary or reversible health problems — stop using it.
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