Regard Dressing change kit, Item Number 800026006
FDA Recall #Z-0596-2024 — Class I — November 20, 2023
Product Description
Regard Dressing change kit, Item Number 800026006
Reason for Recall
ROi CPS manufactured and distributed medical convenience kits with an irrigation solution component which was subsequently recalled by the component manufacturer.
Recalling Firm
ROi CPS LLC — Republic, MO
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Devices
Product Quantity
1830 units
Distribution
US Nationwide distribution in the state of Louisiana.
Code Information
UDI/DI 10194717107873, Lot Numbers: 98283, 97591, 97405, 97081, 96961, 95508, 94769, 94435, 94270
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated