CASMED 500cc Unifusor Classic with piston gauge and stopcock valve. Model : A903SGA. The letter A refers to a special quantity designator for a particular customer. It is designed for use in rapid infusion,invasive pressure monitoring and with auto-transfusion devices.
FDA Recall Z-0466-2009 · Posted 2008-12-29
Advertisement
Recalling FirmCAS Medical Systems, Inc.
Recall StatusTerminated
Product CodeKZD
Date Initiated2008-09-20
Date Terminated2010-08-05
Product Quantity9,744 pc
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.
Firm 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.
Root Cause
Equipment maintenance
Distribution Pattern
Nationwide Foreign: Malaysia, Austria, Belgium, Czech Rep., France, Germany, Greece, Italy, Norway, Spain, Sweden, Switzerland and the UK.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement