Conformable Thoracic Stent Graft, Rx only, Sterile EO - Product Usage: This device is intended for endovascular repair o

FDA device recall Z-2052-2020 · posted 2020-05-20 · Terminated

Recall details

Recalling firm

W L Gore & Associates, Inc.

Reason for recall

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

Action taken

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

Status

Terminated

Product code

MIH

Quantity affected

15 stents

Distribution

International the country of Japan.

Date initiated

2019-12-17

Date posted

2020-05-20

Date terminated

2021-04-28

Location

Flagstaff, AZ