PHS Lacertaion Tray, Sterile, 20 per case, Manufactured for Professional Hosptial Supply, Inc.
FDA Recall #Z-0932-2023 — Class II — December 15, 2022
Product Description
PHS Lacertaion Tray, Sterile, 20 per case, Manufactured for Professional Hosptial Supply, Inc.
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
300 units
Distribution
US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA.
Code Information
Assembly Number 477944, UDI-DI: M7524779441, Lot Numbers: 220974270, 220915145
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated