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U.S. Department of Health and Human Services

Class 2 Device Recall

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 Class 2 Device Recallsee related information
Date Initiated by FirmApril 05, 2023
Date PostedJanuary 14, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0906-2025
Recall Event ID 96002
Product Classification Cabinet, table and tray, anesthesia - Product Code BRY
ProductBD Pyxis MedStation ES (Med ES Main), REF: 323; and BD Pyxis MedStation ES (Med ES Main Tower), REF: 352
Code Information Software v1.7.3. REF/UDI-DI: 323/10885403512667, 352/10885403512674
Recalling Firm/
Manufacturer		 CareFusion 303, Inc.
10020 Pacific Mesa Blvd
San Diego CA 92121-4386
For Additional Information Contact
888-876-7128
Manufacturer 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.
FDA Determined
Cause 2		Software design
ActionOn 4/5/2023, correction notices were sent to customers who were asked to do the following: A permission-based feature called "Global Find" can be used to obtain alternate storage locations of medication(s) not loaded (by pharmacy) or depleted at that device and is not impacted by this issue. 1) Review and confirm that backup procedures (which may include but may not necessarily be limited to keys, emergency medication supplies, alternate devices in proximity, etc.) are in place and staff have all been properly trained on them to avoid delays in access to medications. 2) Ensure this letter is forwarded to applicable facilities if devices have been transferred and that all appropriate personnel have been made aware of this issue. 3) Complete and return the enclosed Customer Response Form via email to BDRC23@bd.com 4) Adverse health consequences experienced with the use of this product should be reported to BD at 1-800-727-6102 or via bd.com/self-service. Recall/Letter Questions: BD Customer Support, Phone: 1-866-583-8783, Phone Hours: 5:00am PST to 4:00pm PST (8:00am ET to 7:00pm ET), Monday - Friday A software update is available. BD will contact you to schedule a time to install the software update.
Quantity in Commerce622
DistributionUS Nationwide distribution in the states of NY, NC, LA.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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