Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets. Used to regulate the flow of primary and secondary fluids when positive pressure is required. The infusion system is capable of delivering fluid from a negative head height (when the IV fluid container is lower than the pump), and provides clinically accepted volumetric accuracy for all standard IV fluids, including blood, lipid, and Total Parenteral Nutrition (TPN). Model number: 621-300ES and 621-400ES. To deliver a broad range of drugs with use with the B. Braun Medical Inc. Horizon Pump IV Sets.
FDA Recall Z-2188-2013 · Posted 2013-09-13
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Reason for Recall
Firm Action
Root Cause
Software design
Distribution Pattern
Nationwide distribution: USA including states of: AR, CA, FL, IL, LA, NC, NJ, NY, MD, ME, MN, SC, TN, TX, VA, WI, and WV.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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