BD Alaris System PC Unit Model 8100 (Pump Module) and Pump Module Door Assembly Replacement Kits (P/N 49000239, 49000346, 49000438, 49000439) infusion pump.
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.
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).
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2939-2020