Recall Z-0463-2009 ยท KZD Infusor, Pressure, For I.V. Bags
CAS Medical Systems, Inc.
CASMED 500cc Unifusor with aneroid gauge and stopcock valve. Model: A803SGA . The letter A refers to a special quantity designator for a particular customer. The product is designed for use in rapid infusion,invasive pressure monitoring and with auto-transfusion devices.
| Date | Dec 29, 2008 (initiated Sep 20, 2008) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 | 19,440 pc |
| Distribution | Nationwide Foreign: Malaysia, Austria, Belgium, Czech Rep., France, Germany, Greece, Italy, Norway, Spain, Sweden, Switzerland and the UK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K893519 | TWIN-FUSOR/UNI-FUSOR BLOOD & FLUID INFUSION CUFF Statlabs, Inc., Aug 15, 1989 |