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.
This recall has been terminated (originally issued December 29, 2008).
- Company
- Cas Medical Systems, Inc.
- Recall Initiated
- September 20, 2008
- Posted
- December 29, 2008
- Terminated
- August 5, 2010
- Recall Number
- Z-0467-2009
- Quantity
- 6,384 pc
- Firm Location
- Branford, CT
- Official Source
- View on FDA website ↗
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.
Distribution
Nationwide Foreign: Malaysia, Austria, Belgium, Czech Rep., France, Germany, Greece, Italy, Norway, Spain, Sweden, Switzerland and the UK.
Lot / Code Info
Lot Numbers:25460908, 27261108, 31141308, 34441608, 34451608, 41352108, 41782108, 42442208, 43452308, 44762408, and 45642508.
Root Cause
Equipment maintenance
Action Taken
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.