Recall Z-2164-2013— B Braun Medical, Inc.

Class II FDA medical device recall by B Braun Medical, Inc., initiated 2012-10-31, terminated 2016-02-03. FDA's recall record names no specific 510(k) clearance for this event. Product: 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: 621-100ES, 621-200ES, 621-300ES, and 621-400ES. To deliver a broad range of drugs with use with the B. Braun Medical Inc. Horizon Pump IV Sets.. Reason: This notice is being provided in follow up to the field correction initiated by B. Braun Medical Inc. on 26 August, 2011 due to an issue in the Outlook ES Safety Infusion System where the Care Area can inadvertently be exited thereby removing DoseGuard dose limit protection. This occurs when a sequence of HOLD - HOLD key strokes are performed on the pump key panel while the user is in the Dose Dat.

Recalling firm

B Braun Medical, Inc.

Classification

Class II

Status

Terminated

Initiated

2012-10-31

Terminated

2016-02-03

Firm location

Carrollton, TX, United States

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