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U.S. Department of Health and Human Services

Class 1 Device Recall Infusomat(R) Space Pump

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 Class 1 Recall
Infusomat(R) Space Pump
see related information
Date Posted July 16, 2012
Recall Status1 Terminated on November 03, 2014
Recall Number Z-1992-2012
Recall Event ID 62115
Premarket Notification
510(K) Numbers
K062700  K083689 
Product Classification Pump, Infusion - Product Code FRN
Product Infusomat(R) Space Pump (US Version) with software version 686G030103 (commonly termed 'G03'), 686E030003, 686F030005, 686F030007, 686G030002, and 686G030102. Intended for use with adults, pediatrics and neonates and is intended to provide infusions of parenteral fluids/medications, blood and blood products indicated for infusion through FDA approved routes of administration.
Code Information Pump Model Numbers: 8713050U, 8713050U-99, 8713050US, 8713060U, and 8713060U-99 -- various serial numbers.
Recalling Firm/
Manufacturer
B. Braun Medical, Inc.
901 Marcon Boulevard
Allentown, Pennsylvania 18109-9512
Manufacturer Reason
for Recall
Firm became aware of the potential for breakage of the anti free flow clip catch, located on the inside of the pump door, when the IV set anti free flow clip is incorrectly inserted into the pump and the pump door forced closed. If the clip catch is broken and the door opened, free flow protection is still ensured. However, after the set is manually removed from the pump without the closure of t
FDA Determined
Cause 2
DESIGN: Device Design
Action B. Braun Medical, Inc. sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated March 23, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to identify the affected product in their inventory and to complete and return the Product Acknowledgement Form via fax to (610)849-1197. Contact the Customer Support Department at (800) 626-7867 for assistance with returning any product or if you have questions regarding this notice.
Quantity in Commerce 38,225 pumps
Distribution Nationwide Distribution-including Puerto Rico and the states of AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NV, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, TN, TX, VT, VA, WA, WV, and WI.
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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