ROi CPS LLC: Medical Device Recall in 2022 - (Recall #: Z-1051-2022)

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:

Regard brand CABG Pack A and B - Spartanburg

Product Classification:

Class II

Date Initiated: March 21, 2022

Date Posted: May 18, 2022

Recall Number: Z-1051-2022

Event ID: 89951

Reason for Recall:

Kits were packed into shipping boxes incorrectly.

Status: Terminated

Product Quantity: 85 kits

Code Information:

Item Number: 800208017, Lot 91156 UDI: (01)10194717112495(17)230101(10)91156

Distribution Pattern:

Recall impacted one domestic consignee in NC

Voluntary or Mandated:

Voluntary: Firm initiated