FDA-Device2023-11-15Class I
Alaris PCA Module 8120
CareFusion 303, Inc.
Hazard
Alaris PCA Module 8120, Patient Controlled Analgesia infusion pump: compatible syringes labeling contains syringes that have not been validated.
Sold states
Worldwide Distribution: US (nationwide): AK, AL, AR, AS, AZ, CA, CO, DC, DE, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MP, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY; OUS (foreign): Canada, Germany, Cuba, Italy, Japan, South Korea, Turkey, United Arab Emirates, Australia, Bahrain, Botswana, Kuwait, Mexico, Netherlands, Philippines, Pakistan, Qatar, South Africa, Singapore, Belgium, Israel, India, New Zealand, Malaysia, Taiwan, Switzerland
Affected count
86,393 units
Manufactured in
10020 Pacific Mesa Blvd, San Diego, CA, United States
Products
Alaris PCA Module 8120
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0186-2024Don't want to check this manually?
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