—#208882

Product

BD PYXIS MEDBANK TWR MN CR-4HH-1FH-4FM-P, REF: 169-90 containing software version 3.9.1.9

FDA product code: BRY — Cabinet, Table And Tray, Anesthesia
Device class: Class 1
Medical specialty: Anesthesiology
Affected lot / code info: UDI: 10885403512568/ Serial Number: 16042128, 16042129, 16044049, 16044052

Why it was recalled

Due to software issue, there is a potential when a restock label is printed for a medication stored in automated dispensing cabinets, that the incorrect bin for the medication is printed on the label.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

On July 11, 2024, CareFusion, subsidiary of Becton, Dickinson and Company (BD) issued a "Urgent Medical Device Correction" Notification, via mail. On June 24, 2024, BD issued Customer Release Notes via their firm's customer portal. BD ask consignees to take the following actions: Clinicians: 1. When restocking the cabinet, refer to the MedBank restock workflow screen to verify the correct bin location rather than the printed label until the software update is provided. Users should verify the contents of the bin location being restocked. 2. Please circulate this notice to all those who require awareness within your organization or to any organization whom you may have transferred BD Pyxis" MedBank" CUBIE" Replenishment Station devices to. 3. Please promptly complete and return the enclosed Customer Response Form within 15 days to acknowledge receipt of this notification and that you understand the information provided in this letter Distributor: 1. Please provide a copy of the attached customer letter to all facilities within your distribution network that have any product listed in Appendix 1. 2. Please promptly complete and return the enclosed Distributor Response Form within 15 days to acknowledge receipt of this notification and that you understand the information provided in this letter.

Recalling firm

Firm: CareFusion 303, Inc.
Address: 10020 Pacific Mesa Blvd, San Diego, California 92121-4386

Distribution

Distribution pattern: US Nationwide distribution including in the states of AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NV, NY, OH, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV.

Timeline

Recall initiated: 2024-06-24
Posted by FDA: 2024-08-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #208882. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.