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U.S. Department of Health and Human Services

Class 2 Device Recall Unifusor Classic

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  Class 2 Device Recall Unifusor Classic see related information
Date Initiated by Firm September 20, 2008
Date Posted December 29, 2008
Recall Status1 Terminated 3 on August 05, 2010
Recall Number Z-0467-2009
Recall Event ID 49495
510(K)Number K893519  
Product Classification Pressure Infusor for I.V. - Product Code KZD
Product CASMED 500cc Unifusor Classic with piston gauge and stopcock valve
Model: 903SGA. It is designed for use in rapid infusion,invasive pressure monitoring and with auto-transfusion devices.
Code Information Lot Numbers:25460908, 27261108, 31141308, 34441608, 34451608, 41352108, 41782108, 42442208, 43452308, 44762408, and 45642508.  
Recalling Firm/
Manufacturer		 CAS Medical Systems, Inc.
44 E Industrial Rd
Branford CT 06405
For Additional Information Contact SAME
203-488-6056
Manufacturer Reason
for Recall		 Leaks: Infusion Cuffs may exhibit air leakage at the union of the tube and bag, and not maintain pressure. For further information, please contact the firm at 203-488-6056.
FDA Determined
Cause 2		 Equipment maintenance
Action CAS Medical Systems notified accounts by letter dated 9/19/08 requesting return and sub-recall be conducted to their accounts. The letter was entitled "UNIFUSOR(R) INFUSION CUFFS AND PRIVATE LABEL (CASMED-MANUFACTURED) INFUSION CUFFS *** URGENT PRODUCT CORRECTION NOTICE." For further information, please contact the firm at 203-488-6056.
Quantity in Commerce 6,384 pc
Distribution Nationwide Foreign: Malaysia, Austria, Belgium, Czech Rep., France, Germany, Greece, Italy, Norway, Spain, Sweden, Switzerland and the UK.
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 = KZD and Original Applicant = STATLABS, INC.
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