Company: CareFusion 303, Inc.
Date of Enforcement Report: 6/24/2025
Class: II
PRODUCT
Product Name [REF]: Supply Server CCE Enterprise SW Site License (2-5) BD Pyxis Logistics [806] BD Pyxis MedStation 4000 Main 10885403512629 [303] BD Pyxis MedStation ES Tower 10885403512674 [352] BD Pyxis Anesthesia Station ES 10885403477836 [327] BD Pyxis MedStation ES (Main) 10885403512667 [323] MD BD Pyxis SupplyStation V9 [317] Security Module [139698-01] BD Knowledge Portal for Medication Technologies [136607-01] STOCKSTN V10.X WRD/WL SCANNERS [132-53-02] PRS STOCKSTN V10.X WRD/WL SCANNERS [132-53-01] STOCKSTN V10.X WIRED SCANNER [132-52-02] PRS STOCKSTN V10.X WIRED SCANNER [132-52-01] BD Pyxis CII Safe ES, Desktop PC [1156-00] BD Pyxis SupplyStation Panel PC V11 [1132-00] BD Pyxis SupplyRoller V11 [1127-00] Dell 640 Server [1128-00] BD Pyxis SupplyStation System V11 [1123-00] BD Pyxis CII Safe ES 10885403512605 [1116-00] BD Pyxis Enterprise Server 10885403518348, 10885403520341 [1115-00] BD Pyxis SupplyRoller V10 [1101-00] BD Pyxis CIISafe, V9.X, SGL IM, BIO 10885403512520 [111-221] BD Pyxis CIISafe, V7.X, DBL INTG MAIN, BIO, SOLID DO [111-194] BD Pyxis CIISafe, V8.X Desktop PC, Bio [107-245-01]
Recall Number:
Z-2017-2025
REASON:
During automated dispensing cabinet upgrade/installation/reimaging, component manager was left in installed mode, and if a Microsoft patch is then installed this may lead to an error preventing user access to the dispensing software application, which may lead to delay in access to medications/supplies, and delivery/replenishment of patient specific orders; which may lead to delay in patient care
RECALLING FIRM/MANUFACTURER:
CareFusion 303, Inc.
VOLUME:
6,313
DISTRIBUTION:
Worldwide – US Nationwide distribution including in the states of PR, DE, GU, MO, IA, IL, CA, MD, MA, VA, PA, NY, WA, NJ, AZ, CO, OH, FL, WI, TX, CT, LA, MI, WY, MN, AR, KY, OR, NM, TN, NC, SC, IN, VT, KS, AL, GA, WV, NV, ID, DC, MS, NE, HI, OK, UT, ND, MT, NH, SD, ME, RI, AK, MP and the countries of SA, CA, NZ , CH, FR, IT, BE, AU, BH, QA, AE, GB, EG, AR, JO, DE, BM, TH, LB, BR, IE, FI, MX, TW, ID, SG, BS, IN, MA, GF, ES, HK
