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.
