PlainRecalls
FDA Devices Moderate Class II Ongoing

Alaris EtCO2 Module Model 8300, a modular infusion pump and monitoring system

Reported: September 25, 2024 Initiated: August 15, 2024 #Z-3140-2024

Product Description

Alaris EtCO2 Module Model 8300, 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.

Details

Recalling Firm
CareFusion 303, Inc.
Units Affected
180
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.
Location
San Diego, CA

Frequently Asked Questions

What product was recalled?
Alaris EtCO2 Module Model 8300, a modular infusion pump and monitoring system. Recalled by CareFusion 303, Inc.. Units affected: 180.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on September 25, 2024. Severity: Moderate. Recall number: Z-3140-2024.