FDA-Device2023-07-12Class II
BD Pyxis CII Safe, Software: V7, REF: 107-96, 107-97, 107-97-201; BD Pyxis CII Safe, Software: V7, REF: 107-223, 107-224, 111-191, 111-192, 111-193, 111-194, 111-195, 111-196, 111-197, 111-198; BD Pyxis CII Safe, Software: V8, 111-199-01, 111-200-01, 111-201-01, 111-202-01, 111-203-01, 111-204-01, 111-205-01, 111-206-01, 107-245-01, 107-246-01; BD Pyxis CII Safe, Software: V9, REF: 107-252-01, 111-215, 111-216, 111-219, 111-221. BD Pyxis CII Safe, Software: ES, REF: 107-254-01, 107-255-01, 1116-
CareFusion 303, Inc.
Hazard
Automated dispensing cabinet devices plugged into any multi-socket outlet power strips may present unacceptable levels of current leakage, which could expose users to system downtime and/or potential electric shock.
Sold states
US Nationwide-Worldwide Distribution: CO, MS, HI, FL, GA, CA, ND, GU, DE, MO, DC, SC, VA, AK, TX, NY, MN, PA, MA, OH, WI, NC, KY, KS, IL, MD, NE, MI, IA, WA, NM, LA, OK, AZ, AR, IN, WY, AL, NJ, SD, NV, TN, OR, WV, ME, ID, CT, UT, RI, MT, PR, NH, VT, AS OUS: GU, KW, AE, SA, NZ, CA, BE ,GB, IT, JP, KR, DE, AU, SG, BH, JO, QA, ES, AT, NL, OM, BM, AT
Affected count
9,906
Manufactured in
10020 Pacific Mesa Blvd, N/A, San Diego, CA, United States
Products
BD Pyxis CII Safe, Software: V7, REF: 107-96, 107-97, 107-97-201; BD Pyxis CII Safe, Software: V7, REF: 107-223, 107-224, 111-191, 111-192, 111-193, 111-194, 111-195, 111-196, 111-197, 111-198; BD Pyxis CII Safe, Software: V8, 111-199-01, 111-200-01, 111-201-01, 111-202-01, 111-203-01, 111-204-01, 111-205-01, 111-206-01, 107-245-01, 107-246-01; BD Pyxis CII Safe, Software: V9, REF: 107-252-01, 111-215, 111-216, 111-219, 111-221. BD Pyxis CII Safe, Software: ES, REF: 107-254-01, 107-255-01, 1116-00, 1117-00; BD Pyxis CII Safe, Software: N/A, REF: 111-113, 111-114, 111-115, 111-160-201, 111-217, 111-218, 111-220, 111-222; Tripp Lite SUPER6TEL Surge Suppressor, REF: CN 200-025. Used with BD Pyxis CII Safe System: v7.x for WES7 User Guide, DIR 10000145747/ v8.1 User Guide, DIR 10000277635/v9.0 User Guide, DIR 10000354270/ ES User Guide v1.8, DIR 10000418517
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2094-2023Don't want to check this manually?
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