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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 06, 2013
Recall Status1 Open
Recall Number Z-2163-2013
Recall Event ID 64147
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, 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.
Code Information Multiple serial numbers affected. Model number: 621-100ES, 621-200ES, 621-300ES, and 621-400ES.
Recalling Firm/
Manufacturer
B Braun Medical, Inc.
1601 Wallace Dr Ste 150
Carrollton, Texas 75006-6690
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
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
FDA Determined
Cause 2
DESIGN: Component Design/Selection
Action B Braun sent an URGENT: MEDICAL DEVICE FIELD CORRECTION letter dated October 24, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact Customer Support at 1-800-627-7867 for questions regarding this notice.
Quantity in Commerce 28,427
Distribution Nationwide Distribution.
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.
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