FDA-Device2024-12-18Class II
BD Pyxis CII Safe ES, REF: 1116-00
CareFusion 303, Inc.
Hazard
Due to a software issue, automated dispensing cabinet devices may open the wrong cubie pocket or position, which can lead to: 1) Unintended and incorrect medication removal, or 2) Potential for a different medication (medication pulled in error) to be refilled/loaded, which may lead to may lead to low inventory or a stockout.
Sold states
Worldwide - US Nationwide distribution including in the states of OK, LA, FL, AR, VA, KY, PA, AL, NC, CA, MN, AK, TX, MI, ME, OH, OR, NY, IL, RI, GA, WI, NH, KS, CO, WA, MO, MD, AZ, SC, NV, WV, NM, IN, NJ, TN, DE, MT, MA, VT, DC, NE, CT, ID, WY, MS, UT, HI, IA, SD, ND, GU, MP, PR and the countries of CA, BR, JP, ES, NZ, AU, FR, AR, MX, IT, CL, TR, SA, MY, CH, IE, TH, SG, KW, BE, DE, PT, QA, MA, FI, AE, EG, BS, GB, BM, GR, BH, KR, MC, PL, LB, HK, IN, IL, MO, IQ, TN, NO, PH, CO, TW, CN, JO, OM.
Affected count
218
Manufactured in
10020 Pacific Mesa Blvd, San Diego, CA, United States
Products
BD Pyxis CII Safe ES, REF: 1116-00
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0672-2025Don't want to check this manually?
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