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RecallWatchMedical Device Safety
Class IIOngoingZ-1375-2025

CareFusion 303, Inc. recalls BD Pyxis: Anesthesia Station ES

CareFusion 303, Inc.San Diego, CA, United StatesReported Mar 26, 2025 · 1 year ago
Legal News Analyst ·

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.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Affected products & lots

  • BD 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
    UDI-DI 327/10885403477836

What the firm is doing

On 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

DistributionShow details

Worldwide - 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.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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