|
Class 2 Device Recall TEG 5000 |
|
Date Initiated by Firm |
January 28, 2011 |
Date Posted |
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
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = JPA and Original Applicant = HAEMOSCOPE CORP.
|
|
|
|