Z-2262-2024 Class II Ongoing

Recalled by CareFusion 303, Inc. — San Diego, CA

FDA device recall Z-2262-2024 was initiated by CareFusion 303, Inc. on May 21, 2024 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 168 software version.

Recall Details

Product Type
Devices
Report Date
Jul 10, 2024
Initiation Date
May 21, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
168 software version

Product Description

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 Pattern

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.

Code Information

UDI: 10885403960123/ Software versions 12.5.1

Source

Dataset
openFDA device recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for Z-2262-2024
openFDA file date
Oct 26, 2026
Loaded by RegDataLab
Oct 27, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.