Recall Z-0907-2009
Virtus, Inc. · initiated November 24, 2008
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).
Codes / lots: Lots SO590, SO1205, and SO1300.
Reason for recall
The inflation tube may come loose at the connection to the cuff during use.
FDA-determined cause: Employee error
Action taken
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.
Details
- Recall number
- Z-0907-2009
- Initiated
- November 24, 2008
- Posted by FDA
- January 23, 2009
- Terminated
- October 22, 2010
- Product code
- KCY – Tourniquet, Pneumatic
- Quantity
- 3654
- Distribution
- Nationwide Distribution --- including state of Wisconsin.
- Recalling firm
- Virtus, Inc., Batesville, IN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0908-2009 | Expressaire, Disposable Tourniquet Cuff 34", 2 line (18), sterile, Manufactured for…The inflation tube may come loose at the connection to the cuff during use. | 11/24/2008Terminated |