Recall Z-0136-2023— W L Gore & Associates, Inc.

Name: FDA recall Z-0136-2023
Creator: U.S. Food and Drug Administration
Published: 2022-09-21

Class II · Ongoing

Class II FDA medical device recall by W L Gore & Associates, Inc., initiated 2022-09-21. FDA's recall record names no specific 510(k) clearance for this event. Product: GORE CARDIOFORM ASD Occluder. cardiovascular implant.. Reason: Due to manufacturing records (Release Test Results) indicating "Failed"..

Recalling firm: W L Gore & Associates, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2022-09-21
Firm location: Flagstaff, AZ, United States

Product description

GORE CARDIOFORM ASD Occluder. cardiovascular implant.

Reason for recall

Due to manufacturing records (Release Test Results) indicating "Failed".

Data sourced from openFDA. This site is unofficial and independent of the FDA.