Alaris SpO2 Module Model 8210 and Model 8220 - 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.
Reported: August 26, 2020 Initiated: June 30, 2020 #Z-2826-2020
Product Description
Alaris SpO2 Module Model 8210 and Model 8220 - 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.
Details
- Recalling Firm
- CareFusion 303, Inc.
- Units Affected
- 8558
- Distribution
- 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.
- Location
- San Diego, CA
Frequently Asked Questions
What product was recalled? ▼
Alaris SpO2 Module Model 8210 and Model 8220 - 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.. Recalled by CareFusion 303, Inc.. Units affected: 8558.
Why was this product recalled? ▼
LED display, which provides infusion or patient monitoring values, on the module may have segments that appear dim.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 26, 2020. Severity: Moderate. Recall number: Z-2826-2020.
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