17

Jul

2024

FDA Recall: Error Can Cause Delay in Accessing Medication

0

Company: CareFusion 303, Inc.
Date of Enforcement Report: 7/17/2024
Class II

PRODUCT

BD Pyxis: MedStation ES (Main), REF: 323; MedStation ES Tower, REF: 352; Anesthesia Station ES, REF: 327; CII Safe ES, REF: 1116-00; CII Safe ES, Desktop PC, Wired Scanner, REF: 107-254-01; CII Safe ES, Desktop PC, Wireless Scanner, REF: 107-255-01; CII Safe ES, Desktop PC, Wired Scanner 1.7.3, REF: 107-256-01; CII Safe ES, Desktop PC, Wireless Scanner 1.7.3, REF: 107-257-01

Recall Number:

Z-2374-2024

REASON:

If automated dispensing cabinets have specific software versions, and Component Manager was configured to “installed mode”, and software patch KB 5033688 was installed in the production environment, then this will lead to an error that prevents the user from accessing the dispensing software application, which may delay accessing medication.

RECALLING FIRM/MANUFACTURER:

CareFusion 303, Inc.

VOLUME OF PRODUCT IN COMMERCE:

326

DISTRIBUTION:

Worldwide – US Nationwide distribution including in the states of OR, KS, NE, LA, ND, OK, AL, AK, WI, WV, WA, NV, PR, TX, CO, OH, CA, MO, IA, AZ, IN, AR, IL, MN, HI, NM, FL, SD, UT, NY, VA, GA, MA, NC and the countries of TW, CA.

About the author

Allison Pate

Allison joined SoftwareCPR in 2022, bringing along over ten years of passion for building teamwork and growth in organizations. This is established in part by the greatest University the South has to offer- Mississippi State.

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