FDA Medical Device Recalls (openFDA)
Virtus, Inc.: Expressaire, Disposable Tourniquet Cuff 34", 2 line (18), sterile, Manufactured for Sammons Preston, A Patterson Medical Company, Cedarburg, WI.; Cuff type A70107011. Each cuff is marked ExpressAire by Sammons Preston and A70107011. 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).
- Recall number
- Z-0908-2009
- Recalling firm
- Virtus, Inc.
- Product
- Expressaire, Disposable Tourniquet Cuff 34", 2 line (18), sterile, Manufactured for Sammons Preston, A Patterson Medical Company, Cedarburg, WI.; Cuff type A70107011. Each cuff is marked ExpressAire by Sammons Preston and A70107011. 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).
- Status
- Terminated
- Initiated
- 2008-11-24
- Posted
- 2009-01-23
- Terminated
- 2010-10-22
- Reason
- The inflation tube may come loose at the connection to the cuff during use.
- Root cause
- 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
- 2304
- Distribution
- Nationwide Distribution --- including state of Wisconsin.
- Lot, serial or model codes
- Lots SO1106, SO2202, SO2227, and SO2232.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KCY
- Firm FEI
- 1824206
- Firm city
- Batesville
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28