CareFusion 303, Inc.: BD Pyxis: MedFlex, REF: 1119-00; MedBank Tower REF: 1145-00; MedBank MedPass, REF: 139088-01 and associated BD Pyxis user/software/safety guides and quick reference guides.

Recall number

Z-1206-2025

Recalling firm

CareFusion 303, Inc.

Product

BD Pyxis: MedFlex, REF: 1119-00; MedBank Tower REF: 1145-00; MedBank MedPass, REF: 139088-01 and associated BD Pyxis user/software/safety guides and quick reference guides.

Status

Open, Classified

Initiated

2025-01-10

Posted

2025-02-21

Terminated

not on file

Reason

Automated dispensing device labeling is being updated to strengthen labeling around manual access to medications to address the risk of potential delays in retrieving contents/ accessing medications that may result from power loss or potential automated dispensing device malfunctions.

Root cause

Labeling design

Action

On 1/10/2025, correction notices were mailed or emailed to Directors of Nursing or Nurse Managers, Directors of Pharmacy or Pharmacist In Charge, and Facility Administrators informing them to take the following actions: Customers should do the following to prevent delays in access: a. Ensure staff are aware of updates to User Guides, including: automated dispensing devices should not be used 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. b. Have device keys available on-site in a secure location known to designated staff c. Train staff on how to manually access the device d. Ensure downtime policies and procedures are implemented and staff are appropriately trained e. Enable Over-ride mode permissions For pharmacies providing automated dispensing device products to clinical users that are not physically located at the pharmacy site, please ensure clinical users are aware of the risk of delay in access and provide access to keys. Firm will be strengthening labeling regarding delays in dispensing medication. Report any issues associated with the above devices via phone at 866-930-9251. Post these notices with the device until labeling has been updated. Complete and return the response form via email to BDRC54@bd.com If you require further assistance, please contact the firm: 1) Technical Support: Website: bd.com/self-service, Phone: 1-866-930-9251, Hours: 24 hours, 7 days a week. 2) BD Recall Operations, BDRC54@bd.com, Fax: (312) 949-0081. 3) Customer Letter Support, Email: PyxisQuestions@BD.com

Quantity

1521

Distribution

US Nationwide distribution including in the states of AZ, FL, NJ, KY, GA, CA, IL, MD, WI, OH, NC, MS, NY, MO, PA, OR, IN, TX, UT, OK, MI, WA, AL, NV, ME, WV, NE, DC, MA, MT, KS, CO, TN, IA, MN, AR, ID, SC, SD, CT, HI, VA, ND, AK, NM, VT, LA, WY.

Lot, serial or model codes

User Guides: i. BD Pyxis MedBank Cabinet User Guide v2.4 ii. BD Pyxis MedBank MedPass User Guide v1.0 iii. BD Pyxis MedBank CR Station User Guide v3.10 iv. BD Pyxis MedBank myQLink Cloud Software User Guide v1.5 v. BD Pyxis Supply Cabinet Safety Guide (for SupplyBank models) Quick Reference Guides: i. BD Pyxis MedBank CR Station QRG (part number 155018-03) ii. BD Pyxis MedBank Cabinet QRG (PN 155023-03) iii. BD Pyxis MedBank RxNow CR Station QRG (PN 155026-03) iv. BD Pyxis MedBank RxNow Solution QRG 2.0 (PN 155027-02) v. BD Pyxis MedBank MedPass QRG (PN 155022-03) vi. BD Pyxis MedBank QFill Station QRG (PN 155020-02) vii. 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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

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

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