PlainRecalls
FDA Devices Moderate Class II Ongoing

Sterile surgical convenience kit: regard Item Number 800706005, LD0091E - OH C-Section Pack.

Reported: May 3, 2023 Initiated: March 22, 2023 #Z-1436-2023

Product Description

Sterile surgical convenience kit: regard Item Number 800706005, LD0091E - OH C-Section Pack.

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.

Details

Recalling Firm
ROi CPS LLC
Units Affected
1,312 kits
Distribution
US Nationwide distribution in the states of FL and MO. There was no foreign/military/government distribution.
Location
Republic, MO

Frequently Asked Questions

What product was recalled?
Sterile surgical convenience kit: regard Item Number 800706005, LD0091E - OH C-Section Pack.. Recalled by ROi CPS LLC. Units affected: 1,312 kits.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on May 3, 2023. Severity: Moderate. Recall number: Z-1436-2023.