Henry Shein CYSTO SET UP PACK, 20 per case. Distributed by Henry Schein.
FDA Recall #Z-0933-2023 — Class II — December 15, 2022
Product Description
Henry Shein CYSTO SET UP PACK, 20 per case. Distributed by Henry Schein.
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
1,040 units
Distribution
US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA.
Code Information
Assembly Number 570-1130, UDI-DI: H65857011301, Lot Numbers: 222990332, 222692396, 222990334, 221013080, 222529321, 220984273, 222692395, 222368551, 220982614, 222992161.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated