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Open, Classified

Various products which were contract sterilized.

FDA Recall Z-0259-2020 · Posted None

Recalling FirmAnewmed Corporation
Recall StatusOpen, Classified
Product CodeDQX
Date Initiated2019-05-23
Product Quantity1,749 devices

Reason for Recall

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

Firm Action

AnewMed Corporation notified customers on about 05/23/2019 via "URGENT NOTICE VOLUNTARY RECAL OF MEDICAL DEVICES" letter sent certified mail. Instructions included to examine inventory for affected devices and either return them to AnewMed for a credit or destroy them. Customers were also instructed to complete and return the provided Reply Card and indicate whether devices will be return or have been discarded. Questions or additional details can be obtained from Rob Bennison or Nykysha Anderson at 770-263-9633, Monday-Friday, 8:30 AM to 4:40 PM Eastern Time.

Root Cause

Other

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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