ROi CPS LLC: Medical Device Recall in 2023 - (Recall #: Z-1434-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

Sterile surgical convenience kit: regard Item Number: 880393003, HT00997C - Cardiac Cath.

Product Classification:

Class II

Date Initiated: March 22, 2023

Date Posted: May 3, 2023

Recall Number: Z-1434-2023

Event ID: 91984

Reason for Recall:

The recalling firm was notified by their supplier that the light handle covers may separate from the light handle and fall off during use. The light handle covers are a kit component.

Status: Ongoing

Product Quantity: 322 kits

Code Information:

Lot #95383, exp. 10/29/2024, UDI (01)10194717105374(17)241029(10)95383.

Distribution Pattern:

US Nationwide distribution in the states of FL and MO. There was no foreign/military/government distribution.

Voluntary or Mandated:

Voluntary: Firm initiated