FDA-Device2020-09-16Class I
BD Alaris System PC Unit Model 8100 (Pump Module) and Pump Module Door Assembly Replacement Kits (P/N 49000239, 49000346, 49000438, 49000439) infusion pump.
CareFusion 303, Inc.
Hazard
Pump Module keypad may exhibit keys that are unresponsive or stuck as a result of fluid ingress potentially resulting in a delay to the start of infusion or interruption of infusion. Delays in an infusion or interruption can cause serious injury or death in high-risk patient populations.
Sold states
Worldwide: US* (AK, AL, AR, AZ, CA, CO, CT, 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); United Arab Emirates (AE); Australia (AU); Canada (CA); Hungary (HU); Israel (IL); Japan (JP)* Kuwait (KW); New Zealand (NZ); Philippines (PH); Qatar (QA); Saudi Arabia (SA); Singapore (SG); Taiwan (TW); Turkey (TR)*. *There are 159 U.S. government and/or military consignees including two located in Japan (JP) and Turkey (TR).
Affected count
248,519
Manufactured in
10020 Pacific Mesa Blvd, San Diego, CA, United States
Products
BD Alaris System PC Unit Model 8100 (Pump Module) and Pump Module Door Assembly Replacement Kits (P/N 49000239, 49000346, 49000438, 49000439) infusion pump.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2939-2020Don't want to check this manually?
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