MEDFLEX, REF: 1119-00; MEDBANK MAIN, REF: 1137-00; MEDFLEX 2.0, REF: 1139-00; MEDBANK TOWER MAIN, REF: 1145-00; MEDBANK

FDA device recall Z-1552-2025 · posted 2025-04-11 · Open, Classified

Recall details

Recalling firm

CareFusion 303, Inc.

Reason for recall

If "Clear All" selected medications is selected on patient profile, the automated dispensing cabinet may allow dispensing of medication without first requiring the RxVerify Validation Code be entered/without validation from a pharmacist, which could lead to unintended and incorrect medication removal.

Action taken

05OCT2023, Customer Release Notes were sent to customers informing them of system release v1.3.4. On 2/18/2025, correction notices were mailed and emailed to Customers, Directors of Pharmacy, and Facility Medication Management Administrators who were informed the following: 1) Customers with system administrator privileges can uncheck the option for the "Clear All" button in the BD Pyxis MedBank Facility Software, which will disable the feature and prevent the button from displaying on the patient profile selection screen. 2) Best practice is to verify the item being removed is accurate against the provider s order, and if available utilize barcode medication administration as an additional check to ensure the correct medication is retrieved prior to administration.1 3) Share and disseminate this notice within your facility network to ensure they are aware of the field action. 4) Complete and return the Customer Response Form via email to BDRC23@bd.com BD Pyxis MedBank Facility Software version 2.5.1.4 within MedBank system release v1.7 is currently available and will address this issue. BD will contact impacted customers to schedule a time for software upgrade. If you have questions contact the firm's Technical Support at 1-866-930-9251 Phone Hours: 24 hours, 7 days a week.

Root cause

Software design

Status

Open, Classified

Product code

BRY

Quantity affected

2679

Distribution

US Nationwide distribution in the states of KS, TX, CA, PA, NJ, FL, IN, AZ, IL, MA, NY, KY, UT, MD, WA, OH, AL.

Date initiated

2023-10-05

Date posted

2025-04-11

Location

San Diego, CA