Recall Z-2188-2013— B Braun Medical, Inc.

Name: FDA recall Z-2188-2013
Creator: U.S. Food and Drug Administration
Published: 2012-11-14

Class I · Terminated

Class I FDA medical device recall by B Braun Medical, Inc., initiated 2012-11-14, terminated 2015-03-06. It names 2 FDA 510(k) clearances: K011975, 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: 621-300ES 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 August 26, 2011 due to an issue in which the Outlook ES Safety Infusion System may halt infusion but the "RUN" Light Emitting Diodes (LEDs) on the front display continue to advance as if the pump were infusing. The pump emits a backup alarm, but there are no visual indicators that the infusion.

Recalling firm: B Braun Medical, Inc.
Classification: Class I
Status: Terminated
Initiated: 2012-11-14
Terminated: 2015-03-06
Firm location: Carrollton, TX, United States

510(k) clearances named in this recall

2 on FDA's record

K011975 — HORIZON OUTLOOK WITH DOSECOMB.Braun Medical, Inc.·cleared 2001-09-19
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: 621-300ES and 621-400ES. To deliver a broad range of drugs with use with the B. Braun Medical Inc. Horizon Pump IV Sets.

Reason for recall

This notice is being provided in follow up to the field correction initiated by B. Braun Medical Inc. on August 26, 2011 due to an issue in which the Outlook ES Safety Infusion System may halt infusion but the "RUN" Light Emitting Diodes (LEDs) on the front display continue to advance as if the pump were infusing. The pump emits a backup alarm, but there are no visual indicators that the infusion

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