| Class 2 Device Recall Unifusor | |
Date Initiated by Firm | September 20, 2008 |
Date Posted | December 29, 2008 |
Recall Status1 |
Terminated 3 on August 05, 2010 |
Recall Number | Z-0462-2009 |
Recall Event ID |
49495 |
510(K)Number | K893519 |
Product Classification |
Pressure Infusor for I.V. - Product Code KZD
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Product | CASMED 500cc Unifusor with aneroid gauge and thumbwheel valve
Model: 803FGA. It is designed for use in rapid infusion,invasive pressure monitoring and with auto-transfusion devices. |
Code Information |
Lot Numbers: 30241308, 22710808, 22720808, 22730808, 23300808, 34391608, 40042008, 41082108, 41752108, 42422208, 44742408, and 45612508. |
Recalling Firm/ Manufacturer |
CAS Medical Systems, Inc. 44 E Industrial Rd Branford CT 06405
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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 | 5,977 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 |
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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.
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510(K) Database | 510(K)s with Product Code = KZD
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