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U.S. Department of Health and Human Services

Class 1 Device Recall B. Braun Outlook

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 Class 1 Recall
B. Braun Outlook
see related information
Date Posted January 10, 2011
Recall Status1 Terminated on May 29, 2014
Recall Number Z-0837-2011
Recall Event ID 57099
Premarket Notification
510(K) Numbers
K011975  K994375 
Product Classification Pump, Infusion - 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.
Recalling Firm/
Manufacturer
B Braun Medical, Inc
1601 Wallace Dr Ste 150
Carrollton, Texas 75006-6690
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 2
DESIGN: 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 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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