Recall StatusOpen, Classified
Date Initiated2025-02-06
Product Quantity727
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.
Firm Action
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
[email protected]
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:
[email protected]
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
Root Cause
Software design
Distribution Pattern
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.