ROi CPS LLC: Medical Device Recall in 2022 - (Recall #: Z-1004-2022)

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: 830014015, LD00199O - C Section Mother; and (2) regard Clinical Packaging Solutions, Item Number: 830014016, LD00199P - C Section Mother.

Product Classification:

Class II

Date Initiated: March 18, 2022

Date Posted: May 4, 2022

Recall Number: Z-1004-2022

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: 290 convenience kits

Code Information:

(1) Item #830014015 - Lot number 87229O, exp. 5/31/2022 (2) Item #830014016 - Lot numbers 87952P, exp. 5/31/2022; 88219P, exp 6/30/2022; 89163, exp. 6/30/2022; 89430, exp. 5/31/2022; 89926, exp. 6/30/2022; 90372, exp, 6/30/2022; 91054, exp. 12/31/2022; and 91443, exp. 5/31/2023.

Distribution Pattern:

US Nationwide distribution in the state of Missouri.

Voluntary or Mandated:

Voluntary: Firm initiated