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Class 2 Device Recall Disposable Tourniquet Cuff |
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Date Initiated by Firm |
November 24, 2008 |
Date Posted |
January 23, 2009 |
Recall Status1 |
Terminated 3 on October 22, 2010 |
Recall Number |
Z-0908-2009 |
Recall Event ID |
50750 |
Product Classification |
Pneumatic Tourniquet - Product Code KCY
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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). |
Code Information |
Lots SO1106, SO2202, SO2227, and SO2232. |
Recalling Firm/ Manufacturer |
Virtus, Inc. 1896 Lammers Pike Batesville Commerce Ctr Batesville IN 47006
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For Additional Information Contact |
Tara Collins 812-933-1121
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Manufacturer Reason for Recall |
The inflation tube may come loose at the connection to the cuff during use.
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FDA Determined Cause 2 |
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 |
2304 |
Distribution |
Nationwide Distribution --- including state of Wisconsin. |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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