FDA-Device2020-08-12Class I
Alaris Pump Module Model 8100
CareFusion 303, Inc.
Hazard
Broken elements on pump module platen such as broken upper hinge post, lower hinge, and membrane frame can occur when the door is forcefully closed on an object, the device is dropped, or if improper cleaners are used on the membrane frame assembly. These may prevent devices from delivering accurate amounts of fluid, which may result in an over infusion, free-flow conditions, or under infusion.
Sold states
US: CA, FL, IN, TX, NC, LA, SC, VA, PA, OK, AZ, IL, KY, UT, AL, GA, TN, MA, MI, OH, AK, OR, MS, CO, NY, WI, KS, MO, MD, NV, AR, AS, ID, VT, NE, NJ, DC, HI, CT, MT, WV, NH, WA, DE, ME, NM, MN, WY, IA, SD, ND, MP, PR, GU. OUS: NL, MX, AU, MY, NZ, ZA, GB, FR, CH, CN, SG, TW, CA, IL, KW, QA, DE, BH, IN, SA, GI, AE, PK, PH, BE
Affected count
1093588
Manufactured in
10020 Pacific Mesa Blvd, San Diego, CA, United States
Products
Alaris Pump Module Model 8100
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2736-2020Don't want to check this manually?
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