Recall Z-2163-2013— B Braun Medical, Inc.

Class II FDA medical device recall by B Braun Medical, Inc., initiated 2012-10-24, terminated 2015-07-27. 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: B. Braun Medical Inc. has become aware of an issue with the Outlook ES Safety Infusion System. The key panel may fail to function as intended if the underlying circuitry fails due to intermittent contact. This issue applies specifically to the HOLD button. If this occurs, the Door Processor (DP) will not receive the desired input from the user. This issue can be observed in pumps with key panels.

Recalling firm

B Braun Medical, Inc.

Classification

Class II

Status

Terminated

Initiated

2012-10-24

Terminated

2015-07-27

Firm location

Carrollton, TX, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.