• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Unifusor

  • 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 2 Device Recall Unifusor 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-0469-2009
Recall Event ID 49495
510(K)Number K893519  
Product Classification Pressure Infusor for I.V. - Product Code KZD
Product CASMED 500cc Unifusor with a short tube. Private labeled for King Systems.
Model: P500BAG. It is designed for use in rapid infusion,invasive pressure monitoring and with auto-transfusion devices.
Code Information Lot numbers: 34041608, 36421708, 49342608, 54413008, and 61753308,
Recalling Firm/
CAS Medical Systems, Inc.
44 E Industrial Rd
Branford CT 06405
For Additional Information Contact SAME
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 5,143 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.