Recall Z-1237-06 ยท MIH System, Endovascular Graft, Aortic Aneurysm Treatment
W L Gore & Assoc, Inc.
GORE TAG THORACIC ENDOPROSTHESIS System, Endovascular Graft, Aortic Aneurysm Treatment, Catalogue Number TG3415, 34mm x 15cm
| Date | Jul 13, 2006 (initiated Apr 28, 2006) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | 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. |
| Quantity | 10 |
| Distribution | Nationwide to: AL, CT, KS, MA, & MN |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.