Stradis Medical, LLC dba Stradis Healthcare Coryell Memorial Hosp Total, Joint Pack - Surgical Kit Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit.

Recommended Action

Per FDA guidance

A copy of the final recall letter was sent to all affected consignees via 1st class USPS mail on February 25, 2022. The consignees were instructed that the use of further distribution of the potentially perforated kits should immediately cease. Instructions were provided to return any unused Surgical Kits with the scope of this recall to Stradis Healthcare s facility in Georgia. Periodic effectiveness checks will be conducted in order to follow-up with consignees to ensure effectiveness.