Sonoclot Analyzer, ACT Machine India, Thromboelastography, Cardiac Surgery, Liver Transplant

Date Initiated by Firm January 28, 2011 Date Posting Updated March 21, 2011 Recall Status 1 Terminated 3 on March 12, 2012 Recall Number Z-1738-2011 Recall Event ID 57809 510(K)Number K002177    Product Classification System, multipurpose for in vitro coagulation studies - Product Code JPA Product TEG 5000 Thrombelastograph Hemostasis Analyzer System; a multipurpose system for in vitro coagulation studies; Haemonetics, Haemoscope Division, Niles, IL 60714; list number 07-022 a multipurpose system for in vitro coagulation studies Code Information list 07-022 (TEG 5000), all serial numbers Recalling Firm/ Manufacturer Haemoscope Division of Haemonetics Corp 6231 W Howard St Niles IL 60714-3403 For Additional Information Contact Ms. Susan Finneran 800-438-2834 Manufacturer Reason for Recall Haemonetics has received a report of smoke from the unit with a power supply failure. FDA Determined Cause  2 Other Action Haemoscope sent letters to all of thei...