ROi CPS LLC: Medical Device Recall in 2024 - (Recall #: Z-0596-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

Regard Dressing change kit, Item Number 800026006

Product Classification:

Class I

Date Initiated: November 20, 2023

Date Posted: January 10, 2024

Recall Number: Z-0596-2024

Event ID: 93525

Reason for Recall:

ROi CPS manufactured and distributed medical convenience kits with an irrigation solution component which was subsequently recalled by the component manufacturer.

Status: Terminated

Product Quantity: 1830 units

Code Information:

UDI/DI 10194717107873, Lot Numbers: 98283, 97591, 97405, 97081, 96961, 95508, 94769, 94435, 94270

Distribution Pattern:

US Nationwide distribution in the state of Louisiana.

Voluntary or Mandated:

Voluntary: Firm initiated