ROi CPS LLC: Medical Device Recall in 2023 - (Recall #: Z-0315-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

Regard CV PK, Item Numbers a) 880289014, b) 880289015; cardiovascular convenience kit

Product Classification:

Class II

Date Initiated: September 21, 2023

Date Posted: November 22, 2023

Recall Number: Z-0315-2024

Event ID: 93204

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.

Status: Ongoing

Product Quantity: 134 units

Code Information:

a) UDI/DI 10194717111702, Lot Numbers: 94114, 95436; b) UDI/DI 10194717117049, Lot Numbers: 96442

Distribution Pattern:

Voluntary or Mandated:

Voluntary: Firm initiated