Z-0907-2009

Expressaire, Disposable Tourniquet Cuff 34", 1 line (18), sterile, Manufactured for Sammons Preston, A...

Name: Z-0907-2009 Expressaire, Disposable Tourniquet Cuff 34", 1 line (18), sterile, Manufactured for Sammons Preston, A...
Creator: Virtus, Inc.
Published: 2008-11-24
License: https://open.fda.gov/license/

Hill-Rom Inc. / initiated 2008-11-24 / Terminated / root cause: manufacturing process

FDA source

Virtus, Inc. began a recall of Expressaire, Disposable Tourniquet Cuff 34", 1 line (18), sterile, Manufactured for Sammons Preston, A Patterson Medical Company, Cedarburg, WI.; Cuff type... on 2008-11-24. The reason FDA records is "The inflation tube may come loose at the connection to the cuff during use". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0907-2009
Status: Terminated
Initiated: 2008-11-24
Posted: 2009-01-23
Terminated: 2010-10-22
Recalling firm: Hill-Rom Inc.
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).
Product code: KCY Tourniquet, Pneumatic
Reason for recall: The inflation tube may come loose at the connection to the cuff during use.
Root cause tag: manufacturing process
FDA 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 in commerce: 3654
Distribution: Nationwide Distribution --- including state of Wisconsin.
Product codes and lots: Lots SO590, SO1205, and SO1300.

Product code KCY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)