ROi CPS LLC: Medical Device Recall in 2021 - (Recall #: Z-1542-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

Regard Dressing Change Tray

Product Classification:

Class II

Date Initiated: March 26, 2021

Date Posted: May 19, 2021

Recall Number: Z-1542-2021

Event ID: 87658

Reason for Recall:

ChloraPrep applicators in the kit can grow organisms that can result in a breach of the applicators package integrity.

Status: Terminated

Product Quantity: 272 trays

Code Information:

Lot Numbers: 86983C, 87081C and 86356C.

Distribution Pattern:

US Nationwide distribution in the state of Louisiana.

Voluntary or Mandated:

Voluntary: Firm initiated