Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall TEG 5000

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall TEG 5000 see related information
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.
-
-