Z-2825-2020 Class II Ongoing
FDA device recall Z-2825-2020 was initiated by CareFusion 303, Inc. on June 30, 2020 and is designated Class II. Reason for recall: LED display, which provides infusion or patient monitoring values, on the module may have segments that appear dim. The recall status is ongoing. Affected quantity: 40671.
Recall Details
- Product Type
- Devices
- Report Date
- August 26, 2020
- Initiation Date
- June 30, 2020
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 40671
Product Description
Alaris EtCO2 Module Model 8300 - Product Usage: is intended to provide trained healthcare caregivers a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps necessary to enter infusion data.
Reason for Recall
LED display, which provides infusion or patient monitoring values, on the module may have segments that appear dim.
Distribution Pattern
Worldwide distribution - U.S. Nationwide distribution including in the states of CO, FL, SC, NY, CA, NC, TX, IL, PA, AZ, LA, IN, MA, MO, AR, WI, HI, OR, OH, NJ, TN, NE, WA, KS, MI, MD, WV, KY, UT, MN, IA, GA, AL, DE, AK, VA, OK, NM, CT, SD, NV, ID, MT, ME, VT, MS, WY, NH, MP, DC, ND, GU, PR, AS, RI and the countries of TR, QA, CA, AE, KW, MX, GI, IL, SA, CH, NL, BE, TW, ZA, PH, CN, AU, IN, FR, MY, NZ, GB, KR, PK, DE, SG, JP, CU, IT, BH.
Code Information
All serial numbers