Recall Z-0259-2020— Anewmed Corporation

Name: FDA recall Z-0259-2020
Creator: U.S. Food and Drug Administration
Published: 2019-05-23

Class II · Ongoing

Class II FDA medical device recall by Anewmed Corporation, initiated 2019-05-23. FDA's recall record names no specific 510(k) clearance for this event. Product: Various products which were contract sterilized.. Reason: The contract sterilizer did not have adequate packaging data to support the 2-year shelf life..

Recalling firm: Anewmed Corporation
Classification: Class II
Status: Ongoing
Initiated: 2019-05-23
Firm location: Tucker, GA, United States

Product description

Various products which were contract sterilized.

Reason for recall

The contract sterilizer did not have adequate packaging data to support the 2-year shelf life.

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