FDA Medical Device Recalls (openFDA)
CareFusion 303, Inc.: BD PYXIS MEDBANK TWR MN CR-10HH-2FH-P, REF: 169-82 containing software version 3.9.1.9
- Recall number
- Z-2488-2024
- Recalling firm
- CareFusion 303, Inc.
- Product
- BD PYXIS MEDBANK TWR MN CR-10HH-2FH-P, REF: 169-82 containing software version 3.9.1.9
- Status
- Open, Classified
- Initiated
- 2024-06-24
- Posted
- 2024-08-02
- Terminated
- not on file
- Reason
- 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
- Under Investigation by firm
- Action
- 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.
- Quantity
- 11 units
- Distribution
- 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.
- Lot, serial or model codes
- UDI: 10885403512568/ Serial Number: 15806714 15949551 16043223 16194366 16122742 16111668 15940148 15931010 15930743 15943757 16203044
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- BRY
- Firm FEI
- 2016493
- Firm city
- San Diego
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28