Stradis Healthcare Foley Catheter Insertion Tray with preconnected bag and catheter, Sterile
FDA Recall #Z-0931-2023 — Class II — December 15, 2022
Product Description
Stradis Healthcare Foley Catheter Insertion Tray with preconnected bag and catheter, Sterile
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
920 units
Distribution
US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA.
Code Information
a. Assembly Number 33066, UDI-DI: M752330661, Lot Numbers: 222782334, 222519530, 222438660; b. Assembly Number 33068, UDI-DI: M752330681, Lot Numbers: 222145412, 220551558, 222508466
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated