Recall Z-2175-2013— B Braun Medical, Inc.

Name: FDA recall Z-2175-2013
Creator: U.S. Food and Drug Administration
Published: 2012-12-05

Class II · Terminated

Class II FDA medical device recall by B Braun Medical, Inc., initiated 2012-12-05, terminated 2014-10-24. It names one FDA 510(k) clearance: K994375. 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, and 621-200ES. To deliver a broad range of drugs with use with the B. Braun Medical Inc. Horizon Pump IV Sets.. Reason: B. Braun Medical Inc. is informing our customers of a field correction previously performed to address the loss of the drug library in the Outlook Pump Models 620-100 and 620-200. This could have occurred after periods of lost DC (battery) power or out of tolerance low power. This could have led to a delay in therapy, or to delivery of an over or under-dose of a therapy if the user was to rely on.

Recalling firm: B Braun Medical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2012-12-05
Terminated: 2014-10-24
Firm location: Carrollton, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K994375 — HORIZON LIGHTB.Braun Medical, Inc.·cleared 2000-03-08

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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, and 621-200ES. To deliver a broad range of drugs with use with the B. Braun Medical Inc. Horizon Pump IV Sets.

Reason for recall

B. Braun Medical Inc. is informing our customers of a field correction previously performed to address the loss of the drug library in the Outlook Pump Models 620-100 and 620-200. This could have occurred after periods of lost DC (battery) power or out of tolerance low power. This could have led to a delay in therapy, or to delivery of an over or under-dose of a therapy if the user was to rely on

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