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

Products covered by this recall
Model / numberProduct as published
1116-00BD Pyxis CII Safe ES
107-254-01and BD Pyxis : CII Safe ES Desktop PC, Wired SCNR
107-255-01CII Safe ES Desktop PC, W-LESS SCNR, BIO
1115-00Enterprise 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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 7:35 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.