FDA recall Z-2262-2024

CareFusion 303, Inc. · Class II · device

Product

BD Alaris System Manager REF: 9601, compatible with BD Alaris PC Units

Reason for recall

Due to a software issue the PC unit may not connect to the server which could impact wireless data transmission to and from the server.

Distribution

US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI.

Key facts

Status
Ongoing
Initiation date
2024-05-21
Report date
2024-07-10
Voluntary/Mandated
Voluntary: Firm initiated
Location
San Diego, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2262-2024