Recall Z-2052-2020— W L Gore & Associates, Inc.
Class II · Terminated
Class II FDA medical device recall by W L Gore & Associates, Inc., initiated 2019-12-17, terminated 2021-04-28. FDA's recall record names no specific 510(k) clearance for this event. Product: Conformable Thoracic Stent Graft, Rx only, Sterile EO - Product Usage: This device is intended for endovascular repair of lesions of the descending thoracic aorta.. Reason: The incorrect label was placed on both the primary and secondary package..
- Recalling firm
- W L Gore & Associates, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-12-17
- Terminated
- 2021-04-28
- Firm location
- Flagstaff, AZ, United States
Product description
Conformable Thoracic Stent Graft, Rx only, Sterile EO - Product Usage: This device is intended for endovascular repair of lesions of the descending thoracic aorta.
Reason for recall
The incorrect label was placed on both the primary and secondary package.
Data sourced from openFDA. This site is unofficial and independent of the FDA.