Recall Z-0944-2023— Stradis Healthcare

Name: FDA recall Z-0944-2023
Creator: U.S. Food and Drug Administration
Published: 2022-12-15

Class II · Ongoing

Class II FDA medical device recall by Stradis Healthcare, initiated 2022-12-15. FDA's recall record names no specific 510(k) clearance for this event. Product: Stradis Healthcare TCTR Convenience Kit. Manufactured by Stradis Healthcare.. Reason: Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit..

Recalling firm: Stradis Healthcare
Classification: Class II
Status: Ongoing
Initiated: 2022-12-15
Firm location: Waukegan, IL, United States

Product description

Stradis Healthcare TCTR Convenience Kit. Manufactured by Stradis Healthcare.

Reason for recall

Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.

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