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U.S. Department of Health and Human Services

Class 2 Device Recall Various BD Pyxis Models

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 Class 2 Device Recall Various BD Pyxis Modelssee related information
Date Initiated by FirmFebruary 06, 2025
Date PostedMarch 17, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1375-2025
Recall Event ID 96202
Product Classification Cabinet, table and tray, anesthesia - Product Code BRY
ProductBD Pyxis: Anesthesia Station ES, REF: 327, MedStation ES, REF: 323, MedStation ES Tower, REF: 352, CII Safe ES, REF: 1116-00, CII Safe ES Desktop PC, REF: 1156-00, CII Safe ES Desktop PC, Wired SCNR, REF: 107-254-01, CII Safe ES Desktop PC, W-less SCNR, REF: 107-255-01, Used with Enterprise Server (ES), REF: 1115-00 with affected Enterprise Server software.
Code Information BD Pyxis Enterprise Server software versions: 1.7.4.128, 1.7.4.134, 1.7.4.136, 1.7.4.137, All 1.7.1, All 1.7.2, All 1.7.3. REF/UDI-DI: 327/10885403477836, 323/10885403512667, 352/10885403512674, 1116-00/10885403512605
Recalling Firm/
Manufacturer		 CareFusion 303, Inc.
10020 Pacific Mesa Blvd
San Diego CA 92121-4386
Manufacturer Reason
for Recall		Sync timeout may occur between the server and automated dispensing device, due to a server software error which may occur if syncing a large amount of data that takes excessive time, which may cause the dispensing devices to become disconnected from the ES server; dispensing devices will not receive updated information, which may lead to incorrect therapy, and delay in accessing medication.
FDA Determined
Cause 2		Software design
ActionOn 2/6/2025, correction notices were mailed to customers informing them of the following: 1) Firm will be contacting customers and distributors to schedule time to upgrade software to 1.7.4.138 or a later release. 2) Identify all customers within your distribution network that purchased any affected product as defined in this notification. Provide a copy of the attached customer letter to all customers to advise them of this field action notification. 3) Complete and return the customer/distributor response form via email to BDRC8@bd.com Report complaints to firm via the North American Regional Complaint Center: Phone: 1-844-8BD-LIFE (1-844-823-5433) Say "Product Complaints" when prompted Mon-Fri 8:00am - 5:00pm CT Email: productcomplaints@bd.com Recall/Remediation Related Questions: 1-866-583-8783, 8:00am ET to 7:00pm ET), Monday - Friday. Product Complaints or Technical Support: 1-800-727-6102 Phone hours: 24 hours, 7 days a week Website: bd.com/self-service
Quantity in Commerce727
DistributionWorldwide - US Nationwide distribution including in the states of KY, OH, NY, MO, NC, PA, FL, TN, CT, LA, MN, VA, MD, CA, TX, NE, IA, OK, MI, PR, SD, IN, ME, KS, IL, NM, WA, AR, HI, MS, GA, WY, WI, VT, AL, NV, NJ, DC, AZ, MT, AK, OR, CO, NH, MA, SC, ID, UT, ND and the countries of TW, CA, AE, MX, SG, AU, NZ, GB, CH, BH.
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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