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Terminated

GORE TAG THORACIC ENDOPROSTHESIS System, Endovascular Graft, Aortic Aneurysm Treatment, Catalogue Number TG3410, 34mm x 10cm

FDA Recall Z-1236-06 · Posted 2006-07-13

Recalling FirmW L Gore & Assoc, Inc.
Recall StatusTerminated
Product CodeMIH
Date Initiated2006-04-28
Date Terminated2006-12-13
Product Quantity10

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.

Firm 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.

Root Cause

Other

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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