Recall Z-0946-2023— Stradis Healthcare

Name: FDA recall Z-0946-2023
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: Tacy Medical, Inc Syringe Convenience Pack, IML L/L, Sterile, 60 packs per bag, 5 bags per case. Manufactured for Tracy Medical, Inc.. 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

Tacy Medical, Inc Syringe Convenience Pack, IML L/L, Sterile, 60 packs per bag, 5 bags per case. Manufactured for Tracy Medical, Inc.

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.