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 Disposable Tourniquet Cuff

  • 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 Disposable Tourniquet Cuff see related information
Date Initiated by Firm November 24, 2008
Date Posted January 23, 2009
Recall Status1 Terminated 3 on October 22, 2010
Recall Number Z-0907-2009
Recall Event ID 50750
Product Classification Pneumatic Tourniquet - Product Code KCY
Product Expressaire, Disposable Tourniquet Cuff 34", 1 line (18), sterile, Manufactured for Sammons Preston, A Patterson Medical Company, Cedarburg, WI.; Cuff type A70107010. Each cuff is marked ExpressAire by Sammons Preston and A70107010.

The tourniquet cuff is placed on a patient's thigh during an operation procedure of the lower leg. The cuff is not operational until it is attached to an air pump supply that is owned by the care giving facility (hospital).
Code Information Lots SO590, SO1205, and SO1300.
Recalling Firm/
Manufacturer		 Virtus, Inc.
1896 Lammers Pike
Batesville Commerce Ctr
Batesville IN 47006
For Additional Information Contact Tara Collins
812-933-1121
Manufacturer Reason
for Recall		 The inflation tube may come loose at the connection to the cuff during use.
FDA Determined
Cause 2		 Employee error
Action Sammons Preston was notified of the recall by letter dated 11/24/08, which instructed them to examine their inventory immediately for the specific lot numbers. The quantity on hand should be indicated on the table attached to the letter and the info should be faxed to Virtus at 812-933-0749. Customers that may have tourniquet cuff inventory of identified lot numbers should be contacted. Once recall items have been located in quarantine, Tara Collins, Quality Technician, should be contacted at 812-933-1121 for Return Material Authorization number.
Quantity in Commerce 3654
Distribution Nationwide Distribution --- including state of Wisconsin.
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.
-
-