ROi CPS LLC: Sterile surgical convenience kits: 1. regard Item Number: 880405003, GS01011C - General Laparoscopy; 2. regard Item Number: 880424004, GS01031D - Thoracic.

Hazard

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.

Details from the source

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. Distribution: US Nationwide distribution in the states of FL and MO. There was no foreign/military/government distribution. Quantity: 278 kits Lot/code info: 1. Lot #95475, exp. 10/29/2024, UDI (01)10194717112211(17)241029(10)95475. 2. Lot #95493, exp. 9/7/2024, UDI (01)10194717112327(17)240907(10)95493.

UPC codes

10194717112211, 10194717112327

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.