Description/REF: BD PYXIS MEDBANK MINI 1FH-1FM/169-137, BD PYXIS MEDBANK MINI 4HM/169-113, BD PYXIS MEDBANK MINI 4HH/169

FDA device recall Z-2321-2025 · posted 2025-08-13 · Open, Classified

Recall details

Recalling firm

CareFusion 303, Inc.

Reason for recall

Reports of delayed access to medication in automated dispensing cabinets because of the override/Add Item workflow.

Action taken

On 7/10/2025, correction notices were mailed and emailed to customers who were informed of the following: Firm strengthened its user guide content regarding manual access to medications. To access the updated content for the user guide and nursing training material, visit the MedBank Customer Portal at https://bd.com/medbankportal When selecting a medication from override/add item function, it is important for users to use extra precautions and verify correct medications are selected and pulled as undesired medications could be displayed on the override list. Firm recommends the following actions to prevent delays in access to medication: 1) Make sure staff know how to use the override/add-item workflow. 2) Have device keys available on-site in a secure location known to designated staff. 3) Train staff on how to manually access the device, see User Guide. 4) Ensure downtime policies and procedures are implemented and staff are appropriately trained Enable Over-ride permission. 5) Do not use the station 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. 6) For pharmacies providing products to clinical users that are not physically located at the pharmacy site, ensure clinical users are aware of the risk of delay in access and provide access to keys. 7) Protocols for retrieving medications from alternative inventory locations 8) Guidance on storing time-sensitive or critical medications outside of automated dispensing devices to prevent access delays. 9) Complete and return the response form via email to BDRC9@bd.com Distributors: provide a copy of this customer letter to any customers who may have received impacted devices. Firm is evaluating design enhancements to improve usability of the override/Add Item workflow. Report any device issues via phone: 866-930-9251

Root cause

Use error

Status

Open, Classified

Product code

BRY

Quantity affected

6076

Distribution

US Nationwide distribution including in the states of NY, MA, KY, VA, OR, OH, FL, WA, MS, OK, TN, PA, RI, TX, SC, AR, MI, NJ, CT, MD, AZ, CA, WV, NC, UT, WY, CO, SD, ID, IL, IN, NV, NM, NE, KS, GA, WI

Date initiated

2025-07-10

Date posted

2025-08-13

Location

San Diego, CA