ROi CPS LLC: Medical Device Recall in 2021 - (Recall #: Z-1376-2021)

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, Item Number 830067009, custom cardiovascular procedure kit

Product Classification:

Class II

Date Initiated: March 4, 2021

Date Posted: April 14, 2021

Recall Number: Z-1376-2021

Event ID: 87472

Reason for Recall:

ROi CPS, LLC has become aware, through a vendor issued urgent medical device recall notice, that drapes contained within select Regard customer procedure trays may have slits in the product that may lead to a breach in the sterile barrier between fluid in the basin and the slush/warming equipment.

Status: Ongoing

Product Quantity: 16 kits

Code Information:

Lot number: 75818I; Expiration Date: 05/18/2021

Distribution Pattern:

US Nationwide distribution in the state of Missouri.

Voluntary or Mandated:

Voluntary: Firm initiated