Stradis Healthcare TCTR Convenience Kit. Manufactured by Stradis Healthcare.
FDA Recall #Z-0944-2023 — Class II — December 15, 2022
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.
Recalling Firm
Stradis Healthcare — Waukegan, IL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
80 units
Distribution
US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA.
Code Information
Assembly Number TCTR01, UDI-DI: M752TCTR011, Lot Numbers: 222014334
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated