BD Pyxis MedStation ES (Med ES Main), REF: 323; and BD Pyxis MedStation ES (Med ES Main Tower), REF: 352
Summary
The FDA issued a Class II for BD Pyxis MedStation ES (Med ES Main), REF: 323; and BD Pyxis MedStation ES (Me by CareFusion 303, Inc.. Reason: Due to an automated dispensing cabinet software issue, when a medication single order contains more than one component and at least one is unavailable.
Details
Source
Device Recall
External ID
Z-0906-2025
Action Date
2025-01-22
Status
Ongoing
Category
device
Product Description
BD Pyxis MedStation ES (Med ES Main), REF: 323; and BD Pyxis MedStation ES (Med ES Main Tower), REF: 352
Lot/Code Info: Software v1.7.3. REF/UDI-DI: 323/10885403512667, 352/10885403512674
Quantity Affected: 622
Reason for Recall
Due to an automated dispensing cabinet software issue, when a medication single order contains more than one component and at least one is unavailable for a multi-item or combination order, the order may display as grayed out; alternate location tooltip will display "Server connection failed," not listing other area devices where unavailable item(s) may be found, which may lead to delayed therapy.
Distribution
US Nationwide distribution in the states of NY, NC, LA.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-04-05
Company
San Diego, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 249 device recalls issued in the same week, part of 413 device-related FDA actions this month.
CareFusion 303, Inc. has 105 FDA actions in our database, including 103 recalls and 2 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (CareFusion 303, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does CareFusion 303, Inc. have FDA actions?
CareFusion 303, Inc. has 105 FDA actions in our database, including 103 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0906-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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