BD Pyxis: MedFlex, REF: 1119-00; MedBank Tower REF: 1145-00; MedBank MedPass, REF: 139088-01 and associated BD Pyxis user/software/safety guides and quick reference guides.
Recall
- Recall Number
- Z-1206-2025
- Event Number
- 96150
- Firm
- CareFusion 303, Inc.
- FEI Number
- 2016493
- Product Code
- BRY
- Status
- Open, Classified
- Root Cause
- Labeling design
- Initiated
- January 10, 2025
- Posted
- February 21, 2025
- Address
- 10020 Pacific Mesa Blvd, San Diego, CA, 92121-4386
Description
BD Pyxis: MedFlex, REF: 1119-00; MedBank Tower REF: 1145-00; MedBank MedPass, REF: 139088-01 and associated BD Pyxis user/software/safety guides and quick reference guides.
Automated dispensing device labeling is being updated to strengthen labeling around manual access to medications to address the risk of potential delays in retrieving contents/ accessing medications that may result from power loss or potential automated dispensing device malfunctions.
On 1/10/2025, correction notices were mailed or emailed to Directors of Nursing or Nurse Managers, Directors of Pharmacy or Pharmacist In Charge, and Facility Administrators informing them to take the following actions: Customers should do the following to prevent delays in access: a. Ensure staff are aware of updates to User Guides, including: automated dispensing devices should not be used as a crash cart or code box. Medication or items may not be immediately accessible for an emergent situation causing a delay in treatment which could lead to serious injury or death. b. Have device keys available on-site in a secure location known to designated staff c. Train staff on how to manually access the device d. Ensure downtime policies and procedures are implemented and staff are appropriately trained e. Enable Over-ride mode permissions For pharmacies providing automated dispensing device products to clinical users that are not physically located at the pharmacy site, please ensure clinical users are aware of the risk of delay in access and provide access to keys. Firm will be strengthening labeling regarding delays in dispensing medication. Report any issues associated with the above devices via phone at 866-930-9251. Post these notices with the device until labeling has been updated. Complete and return the response form via email to [email protected] If you require further assistance, please contact the firm: 1) Technical Support: Website: bd.com/self-service, Phone: 1-866-930-9251, Hours: 24 hours, 7 days a week. 2) BD Recall Operations, [email protected], Fax: (312) 949-0081. 3) Customer Letter Support, Email: [email protected]
US Nationwide distribution including in the states of AZ, FL, NJ, KY, GA, CA, IL, MD, WI, OH, NC, MS, NY, MO, PA, OR, IN, TX, UT, OK, MI, WA, AL, NV, ME, WV, NE, DC, MA, MT, KS, CO, TN, IA, MN, AR, ID, SC, SD, CT, HI, VA, ND, AK, NM, VT, LA, WY.
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