FDA recall Z-3142-2024

CareFusion 303, Inc. · Class II · device

Product

Alaris Pump Module Model 8100, a modular infusion pump and monitoring system

Reason for recall

Due to affected devices that may have bent female IUI connector and may not be operable and potentially cause delays in the start of the infusion or monitoring.

Distribution

Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, Guam, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV. The countries of United Arab Emirates, Australia, Belgium, Canada, Hungary, Kuwait, Qatar, Saudi Arabia, Singapore, Taiwan, and New Zealand.

Key facts

Status
Ongoing
Initiation date
2024-08-15
Report date
2024-09-25
Voluntary/Mandated
Voluntary: Firm initiated
Location
San Diego, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3142-2024