FDAFDA · Food and drugs·Recall number Z-2823-2020
Alaris Syringe Module Model 8110 - 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.
Published August 26, 2020 · Recall initiated: June 30, 2020
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
LED display, which provides infusion or patient monitoring values, on the module may have segments that appear dim.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- CareFusion 303, Inc.
- Distributor
- 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.
- Lot
- All serial numbers
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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