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Terminated

Conformable Thoracic Stent Graft, Rx only, Sterile EO - Product Usage: This device is intended for endovascular repair of lesions of the descending thoracic aorta.

FDA Recall Z-2052-2020 · Posted 2020-05-20

Recalling FirmW L Gore & Associates, Inc.
Recall StatusTerminated
Product CodeMIH
Date Initiated2019-12-17
Date Terminated2021-04-28
Product Quantity15 stents

Reason for Recall

The incorrect label was placed on both the primary and secondary package.

Firm Action

On 12/17/2019, the firm's field representatives hand delivered an URGENT MEDICAL DEVICE RECALL Notification to customers informing them of a label issue with their stents. Two (2) of the 20 units in their work order are labeled with the incorrect part number and size on both the package and carton labels. Customers are instructed to: return the affected products for replacement and If customers have any questions or concern to contact Field Sales Associates for assistance at Telephone number: 03-6746-2560, FAX number: 03-6746-2561

Root Cause

Labeling Change Control

Distribution Pattern

International the country of Japan.

Official Source

View FDA Recall →

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

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