Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 1 Device Recall B. Braun Outlook

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 1 Device Recall B. Braun Outlook see related information
Date Initiated by Firm August 24, 2010
Date Posted January 10, 2011
Recall Status1 Terminated 3 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.
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 2		 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 and Original Applicant = B. BRAUN MEDICAL, INC.
-
-