HCT 12 CC SYRINGE KIT, 20/TRAY,5 TRAYS/BAG, 5 BAGS /CASE HCT. Distributed by Health Care Technol...
FDA Recall #Z-0938-2023 — Class II — December 15, 2022
Product Description
HCT 12 CC SYRINGE KIT, 20/TRAY,5 TRAYS/BAG, 5 BAGS /CASE HCT. Distributed by Health Care Technology.
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
112,675 units
Distribution
US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA.
Code Information
Assembly Number HCT3548-2, UDI-DI: M752HCT354821, Lot Numbers: 222770947, 221809694, 221938965, 221748547, 221578546, 221808445, 221386002, 222859338, 222940522, 221938972
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated