Regard CV PK, Item Numbers a) 880289014, b) 880289015; cardiovascular convenience kit
FDA Recall #Z-0315-2024 — Class II — September 21, 2023
Product Description
Regard CV PK, Item Numbers a) 880289014, b) 880289015; cardiovascular convenience kit
Reason for Recall
Specific Regard kits contain the Gentige Chest Drain Products being recalled by Gentige. The Instructions for Use (IFU) for the chest drains do not provide sufficient precaution instruction for proper set up of catheter(s) and patient tube connections with single collection chamber chest drains.
Recalling Firm
ROi CPS LLC — Republic, MO
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
134 units
Distribution
MO
Code Information
a) UDI/DI 10194717111702, Lot Numbers: 94114, 95436; b) UDI/DI 10194717117049, Lot Numbers: 96442
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated