—#208872

Product

BD PYXIS MEDBANK MINI CR-2HH-1FH-P, REF: 169-114 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: 10885403512544/ Serial Number: 16132658 16168374 16097985 16191227 16221557 16203700 16198296 16034793 16207656 16221556 16225067 16138830 16039764 15950395 16042993 15967360 15378118 16155519 16090203 16216083 16112389 16035948 16256357 15940923 15940150 15961968 15950397 15950399 16055233 15442769 16243553 15832653 16085678 16044038 16044042 16044015 16044016 16044019 16044022 16044021 16044034 16044026 16044032 16044027 16044029 16044031 16044046 15499064 15948854 15490767 15631138 15378120 15378121 15409640 15910842 15353919 15547821 15049511 15618006 15371604 15872431 15657867 15364475 15506571 15326870 15906089 15906091 15906093 15328486 15442778 15506570 16061648 16061659 16061660 16034792 15353916 16161290 16271157 16271158 16271159 16042049 16042051 16042052 16042053

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 #208872. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.