Regard Kit containing the Microtek decanter
FDA Recall #Z-2685-2024 — Class II — June 17, 2024
Product Description
Regard Kit containing the Microtek decanter
Reason for Recall
Decanters may have pin holes and tears in sterile packaging that cannot be identified visually.
Recalling Firm
ROi CPS LLC — Republic, MO
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
78 Kits
Distribution
US Nationwide distribution in the state of MO.
Code Information
Item Number: 830099009; UDI: 10194717116677; Lot number's 99206 (Expiration Date: 2024-09-15) and 100633 (Expiration Date: 2024-09-15)
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated