GORE TAG THORACIC ENDOPROSTHESIS System, Endovascular Graft, Aortic Aneurysm Treatment, Catalogue Number TG3410, 34mm x 10cm
Hazard
Two lots of uniquely different product were switched and mislabeled with the wrong length. 34mm x 10cm devices were mislabeled as 34mm x 15cm and vice versa.
What You Should Do
Remedy
All the letters were sent via Federal Express to each Gore Field Sales Associate (FSA) to be hand-delivered to the Physician and to the hospital Risk Manager. A cover note to the FSA directing them regarding the hand delivery of the letter. Also included is a memo to the FSA with a document that the FSA is directed to complete, sign/date and return to Gore documenting hand-delivery of each of these letters. These letters were to be hand delivered on 18 May, or 19 May, 2006.
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Products
GORE TAG THORACIC ENDOPROSTHESIS System, Endovascular Graft, Aortic Aneurysm Treatment, Catalogue Number TG3410, 34mm x 10cm
- Brand
- W L Gore & Assoc, Inc.
- UPC
- Lot numbers: 04150282, 04150283, 04150284, 04150285, 04150286, 04150287, 04150288, 04150289, 04150290, & 04150291
Units Affected
10