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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
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 Class 1 Recall
B. Braun Outlook		see related information
Date Posted January 10, 2011
Recall Number Z-0837-2011
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
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.
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
 
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