Z-1207-2023 Class II Ongoing
FDA device recall Z-1207-2023 was initiated by CareFusion 303, Inc. on February 14, 2023 and is designated Class II. Reason for recall: Automated dispensing cabinet drawer firmware may have inadvertently been downgraded to an earlier version of drawer firmware during new device installations or device replacement upgrades, which may l… The recall status is ongoing. Affected quantity: 7914.
Recall Details
- Product Type
- Devices
- Report Date
- March 29, 2023
- Initiation Date
- February 14, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7914
Product Description
BD Pyxis Anesthesia ES System (PAS ES), REF: 327; BP Pyxis MedStation ES (Med ES Main), REF: 323; BD Pyxis MedStation ES Tower (Med ES Tower), REF: 352; all with BD Pyxis ES version 1.6.1 drawer firmware (version 1.10.2.5). Pyxis MedStation Enterprise Server (ES) System is an automated medication dispensing system supporting decentralized medication management in a pharmaceutical environment.
Reason for Recall
Automated dispensing cabinet drawer firmware may have inadvertently been downgraded to an earlier version of drawer firmware during new device installations or device replacement upgrades, which may lead to an increased frequency of drawer failures, which could increase the likelihood of patients experiencing delays in receiving medications.
Distribution Pattern
Worldwide - US Nationwide distribution including in the states of NY, PA, OH, TX, FL, KY, IL, DE, AK, WI, KS, LA, WA, AZ, CO, MI, IN, TN, SD, AR, MO, CA, NV, MA, SC, VA, WV, CT, ME, NE, RI, GA, NC, IA, MN, AL, OK, MS, NM, NH, VT, WY, OR, ID, NJ, UT, DC, HI, MD, MT, ND and the country of Canada.
Code Information
REF/UDI-DI: 327/10885403477836, 323/10885403512667, 352/10885403512674