ROi CPS LLC: Medical Device Recall in 2022 - (Recall #: Z-1407-2022)

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:

Nonsterile convenience kits: (1) regard Item #830099008, CV01005H - CV Part 1 Bundle; and (2) regard Item #830019017, CV00214Q - CV.

Product Classification:

Class II

Date Initiated: June 3, 2022

Date Posted: July 27, 2022

Recall Number: Z-1407-2022

Event ID: 90492

Reason for Recall:

Some nonsterile components that were supposed to be sterile were packaged in nonsterile kits.

Status: Terminated

Product Quantity: 86 kits

Code Information:

(1) Item #830099008 - Lot #92534, exp. 11/13/2022, UDI #10194717114895; (2) Item #830019017 - Lot #92612, exp. 8/31/2023, UDI #10194717113249.

Distribution Pattern:

Distribution was made to MO. There was no foreign/military/government distribution.

Voluntary or Mandated:

Voluntary: Firm initiated