TEG 5000 India - Recall from Customers

Date Initiated by Firm	January 28, 2011
Date Posting Updated	March 21, 2011
Recall Status1	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 their U.S. accounts on January 24, 2011, via certified mail. The letters listed guidelines regarding proper use of the TEG 5000 System Power Supply to eliminate any potential risks such as electrical shorting or power supply damage. The information, which was printed in the letter, will also be available in an updated TEG User Manual soon to be released. A Caution label with installation instructions was included with the letter, to be applied to the back of the TEG unit. The accounts were requested to complete the enclosed acknowledgement form and fax it back to Haemoscope at 847-588-0455. Any questions were directed to 1-800-438-2834.
Quantity in Commerce	1,155 units
Distribution	Nationwide Distribution including CA, FL, MD, PA, OH, SC, TN, TX, and VA
Total Product Life Cycle	TPLC Device Report

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97481