ROi CPS LLC: Medical Device Recall in 2020 - (Recall #: Z-0524-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.
Product Description:

Regard - Product Usage: Obstetric Gynecologic specialized manual instrument. Labor and delivery kits.

Product Classification:

Class II

Date Initiated: October 12, 2020
Date Posted: December 9, 2020
Recall Number: Z-0524-2021
Event ID: 86626
Reason for Recall:

Labeling error, incorrect expiration date.

Status: Terminated
Product Quantity: 220 kits
Code Information:

Lot Numbers: 78483C, 79932C, 81043C, 82586C, 83090C.

Distribution Pattern:

US Nationwide distribution in the states of MO and OK.

Voluntary or Mandated:

Voluntary: Firm initiated