FDA-Device2019-11-06Class II
Various products which were contract sterilized.
Anewmed Corporation
Hazard
The contract sterilizer did not have adequate packaging data to support the 2-year shelf life.
Sold states
Nationwide distribution in the states of AL, CO, FL, IN, KY, MS, NC, OH, SC, TN, TX.
Affected count
1,749 devices
Manufactured in
2177 Flintstone Dr Ste O, Tucker, GA, United States
Products
Various products which were contract sterilized.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0259-2020Don't want to check this manually?
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