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).
FDA Recall Z-0908-2009 · Posted 2009-01-23
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Recalling FirmVirtus, Inc.
Recall StatusTerminated
Product CodeKCY
Date Initiated2008-11-24
Date Terminated2010-10-22
Product Quantity2304
Reason for Recall
The inflation tube may come loose at the connection to the cuff during use.
Firm 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.
Root Cause
Employee error
Distribution Pattern
Nationwide Distribution --- including state of Wisconsin.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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