FDA-Device2024-06-12Class II
Alaris Pump Infusion Set Low Sorbing Tubing (PE Lined) Back Check Valve 2 SmartSite Y Sites REF 10013072 Tubing set used for delivery of fluids, medication, blood and blood products.
BD SWITZERLAND SARL
Hazard
Due to infusion set tubing drip chamber becoming detached from the tubing potentially causing delays in treatment, or unintentionally exposing users to harsh infusates.
Sold states
Worldwide - US Nationwide distribution in the states of AR, CA, CO, IL, KS, MA, ME, NJ, NY, PA, SD, WA and WI. The country of Canada.
Affected count
11.300 sets
Manufactured in
Terre Bonne Park A4, Route De Crassier 17, Eysins, N/A, Switzerland
Products
Alaris Pump Infusion Set Low Sorbing Tubing (PE Lined) Back Check Valve 2 SmartSite Y Sites REF 10013072 Tubing set used for delivery of fluids, medication, blood and blood products.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1944-2024Don't want to check this manually?
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