FDA recall Z-0259-2020

Anewmed Corporation · Class II · device

Product

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.

Distribution

Nationwide distribution in the states of AL, CO, FL, IN, KY, MS, NC, OH, SC, TN, TX.

Key facts

Status
Ongoing
Initiation date
2019-05-23
Report date
2019-11-06
Voluntary/Mandated
Voluntary: Firm initiated
Location
Tucker, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0259-2020