Class 1 Device Recall B. Braun Outlook

• Date Initiated by Firm: August 24, 2010
• Date Posted: January 10, 2011
• Recall Status: Terminated on May 29, 2014
• Recall Number: Z-0837-2011
• Recall Event ID: 57099
• 510(K)Number: K011975 K994375
• Product Classification: Infusion pump - Product Code FRN
• Product: Outlook 400ES Safety Infusion System, Model Number 621-400ES. For use with B. Braun Medical Inc. Horizon Pump IV Sets
• Code Information: Model No. 621-400ES. Premarket Notifications K011975 and K994375. Device Listings D051037 and D051592.
• FEI Number: 1641965
• Recalling Firm/ Manufacturer: B Braun Medical, Inc; 1601 Wallace Dr Ste 150; Carrollton TX 75006-6690
• For Additional Information Contact: 972-245-2243
• Manufacturer Reason for Recall: Possible pump stop with audible alarm, but no visual error indication that the pump is not delivering the medication. Under certain conditions in a network environment, Management Processor may become non-responsive, ceasing normal operation.
• FDA Determined Cause: Component design/selection
• Action: B. Braun Medical Inc. notified consignee by letter on August 24, 2010.
• Quantity in Commerce: 2,107 Pumps (582 Pumps to Winchester)
• Distribution: Virginia and New York
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = FRN