GORE TAG THORACIC ENDOPROSTHESIS System, Endovascular Graft, Aortic Aneurysm Treatment, Catalogue Number TG3415, 34mm x

FDA device recall Z-1237-06 · posted 2006-07-13 · Terminated

Recall details

Recalling firm

W L Gore & Assoc, Inc.

Reason for recall

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.

Action taken

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.

Root cause

Other

Status

Terminated

Product code

MIH

Quantity affected

10

Distribution

Nationwide to: AL, CT, KS, MA, & MN

Date initiated

2006-04-28

Date posted

2006-07-13

Date terminated

2006-12-13

Location

Flagstaff, AZ