Reported Oct 18, 2023 · Ongoing
BD Pyxis CII Safe ES, REF: 1116-00; and BD Pyxis : CII Safe ES Desktop PC, Wired SCNR, REF: 107-254-01; CII Safe ES…
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?
4 of 4 products
| Model / number | Product as published |
|---|---|
1116-00 | BD Pyxis CII Safe ES |
107-254-01 | and BD Pyxis : CII Safe ES Desktop PC, Wired SCNR |
107-255-01 | CII Safe ES Desktop PC, W-LESS SCNR, BIO |
1115-00 | Enterprise Server, , 134157-01, 137670-02, 134148-01, 135292-01, 136449-01, 133760-01 |
- Lot codes and dates
- REF1116-00
- UDI-DI10885403512605
- Software Versions1.7.3 and 1.7.4 (Limited commercial release)
- Amount recalled
- 61
Where it was sold
Why it was recalled
When global edit is used to update multiple formulary properties simultaneously, the following properties: 1) Require Lot Number on Recall, 2) Access Destruction Bin (Witness), 3) Add to Destruction Bin (Count/Empty), 4) CII Safe Stock Out Notice are, without user warning, overwritten to the value NO , which could result in diversion of controlled substances from the automated dispensing cabinet.
This product could cause temporary or reversible health problems — stop using it.
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