FDA-Device2023-11-15Class I
BD Alaris PCU REF 8015
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
867,362 units
Manufactured in
10020 Pacific Mesa Blvd, San Diego, CA, United States
Products
BD Alaris PCU REF 8015
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0184-2024More CareFusion 303, Inc. recalls
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