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U.S. Department of Health and Human Services

Class 2 Device Recall Outlook ES Safety Infusion System

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 Class 2 Recall
Outlook ES Safety Infusion System
see related information
Date Posted September 10, 2013
Recall Status1 Open
Recall Number Z-2175-2013
Recall Event ID 64150
Premarket Notification
510(K) Number
K994375 
Product Classification Pump, Infusion - Product Code FRN
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.
Code Information Models 620-100 and 620-200; multiple serial numbers
Recalling Firm/
Manufacturer
B Braun Medical, Inc.
1601 Wallace Dr Ste 150
Carrollton, Texas 75006-6690
Manufacturer 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
FDA Determined
Cause 2
DESIGN: Component Design/Selection
Action The firm, B. Braun Medical Inc., sent an "URGENT: MEDICAL DEVICE FIELD CORRECTION" letter dated December 05, 2012 to its customers. The letter describes the product, problem and actions taken. The firm finished performing "field upgrades" on March 20, 2010 for this issue. Should you require any additional information, please do not hesitate to contact B. Braun Medical Inc., Infusion Systems Customer Service at 1-800-627-7867 (627-PUMP).
Quantity in Commerce 14,161
Distribution Worldwide Disribution: USA (nationwide) and country of: Canada.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FRN and Original Applicant = B. BRAUN MEDICAL, INC.
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