McCormick Medical Distribution PORT TRAY, 25 trays per case. Distributed by McCormick Medical Di...
FDA Recall #Z-0943-2023 — Class II — December 15, 2022
Product Description
McCormick Medical Distribution PORT TRAY, 25 trays per case. Distributed by McCormick Medical Distribution.
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
250 units
Distribution
US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA.
Code Information
Assembly Number MC-3535PT, UDI-DI: M752MC3535PT1, Lot Numbers: 220673037, 222096813
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated