regard Operative LAP, Item Number 800943001; surgical convenience kit
FDA Recall #Z-0620-2024 — Class I — December 18, 2023
Product Description
regard Operative LAP, Item Number 800943001; surgical convenience kit
Reason for Recall
Surgical convenience kits were manufactured with a component which was subsequently recalled by Nurse Assist.
Recalling Firm
ROi CPS LLC — Republic, MO
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Devices
Product Quantity
345 units
Distribution
US distribution to Louisiana
Code Information
UDI/DI 10194717111863, Lot Numbers: 94792, 95613, 96003, 96845
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated