Sterile surgical convenience kit: regard Item Number 800706005, LD0091E - OH C-Section Pack.
FDA Recall #Z-1436-2023 — Class II — March 22, 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.
Recalling Firm
ROi CPS LLC — Republic, MO
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
1,312 kits
Distribution
US Nationwide distribution in the states of FL and MO. There was no foreign/military/government distribution.
Code Information
Lot #95165, exp. 10/27/2024, UDI (01)10194717116387(17)241027(10)95165; lot #95374, exp. 10/17/2024, UDI (01)10194717116387(17)241017(10)95374; and lot #95615, exp. 11/15/2024, UDI (01)10194717116387(17)241115(10)95615.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated