Conformable Thoracic Stent Graft, Rx only, Sterile EO - Product Usage: This device is intended for endovascular repair of lesions of the descending thoracic aorta.
- Company
- W L Gore & Associates, Inc.
- Recall Initiated
- December 17, 2019
- Posted
- May 20, 2020
- Terminated
- April 28, 2021
- Recall Number
- Z-2052-2020
- Quantity
- 15 stents
- Firm Location
- Flagstaff, AZ
Reason for Recall
The incorrect label was placed on both the primary and secondary package.
Distribution
International the country of Japan.
Lot / Code Info
Part number of the device is TGM343420J Serial numbers: 21225065 21225066 21225067 21225068 21225069 21225070 21225071 21225072 21225073 21225074 21225075 21225076 21225077 21225078 21225079 21225080 21225081 21225082 21225083 21225084
Root Cause
Labeling Change Control
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