ROi CPS LLC: Medical Device Recall in 2022 - (Recall #: Z-1005-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

Convenience kits containing regard IV Start Kits: (1) regard Clinical Packaging Solutions, Item Number: 830015013, LD00200M - Vag Delivery Mother; and (2) regard Clinical Packaging Solutions, Item Number: 830084003, LD00866C - Vag Delivery Mother.

Product Classification:

Class II

Date Initiated: March 18, 2022

Date Posted: May 4, 2022

Recall Number: Z-1005-2022

Event ID: 89875

Reason for Recall:

A drug kit component was recalled by its manufacturer due to the potential for inadequacy of the validation of test methods used in its manufacture.

Status: Terminated

Product Quantity: 1,501 convenience kits

Code Information:

(1) Item Number: 830015013 - Lot numbers 87230M, exp. 5/31/2022; 87954M, exp. 5/31/2022; 88285M, exp. 5/31/2022; 88999M, exp. 6/30/2022; 89494, exp. 5/31/2022; 89985, exp. 6/30/2022; 90866, exp. 6/30/2022; and 91603, exp. 5/31/2023; and (2) Item 830084003 - Lot numbers 86155C, exp. 3/31/2022; 84799C, exp. 3/31/2022; 86735C. exp. 3/31/2022, 87269C, exp. 7/31/2022; 87871C, exp. 7/31/2022; 88564C, exp. 1/31/2023; 89260, exp. 2/28/2023; 89820, exp. 2/28/2023; 90253, exp. 1/31/2023; 90594, exp. 12/31/2022; and 91335, exp. 12/31/2022.

Distribution Pattern:

US Nationwide distribution in the state of Missouri.

Voluntary or Mandated:

Voluntary: Firm initiated