Expressaire, Disposable Tourniquet Cuff 34", 2 line (18), sterile, Manufactured for Sammons Preston, A Patterson Medical
FDA device recall Z-0908-2009 · posted 2009-01-23 · Terminated
Recall details
- Recalling firm
- Virtus, Inc.
- Reason for recall
- The inflation tube may come loose at the connection to the cuff during use.
- 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.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- KCY
- Quantity affected
- 2304
- Distribution
- Nationwide Distribution --- including state of Wisconsin.
- Date initiated
- 2008-11-24
- Date posted
- 2009-01-23
- Date terminated
- 2010-10-22
- Location
- Batesville, IN
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