PlainRecalls
FDA Devices Moderate Class II Terminated

REGARD Basic Cataract tray

Reported: November 24, 2021 Initiated: August 10, 2021 #Z-0250-2022

Product Description

REGARD Basic Cataract tray

Reason for Recall

Povidone-Iodine swabstick manufactured by PDI, Inc. recalled due to Out of Specifications was used as a component in some of the ROI CPS, LLC products.

Details

Recalling Firm
ROi CPS LLC
Units Affected
126 trays
Distribution
US Nationwide in the states of FL, LA and MO.
Location
Republic, MO

Frequently Asked Questions

What product was recalled?
REGARD Basic Cataract tray. Recalled by ROi CPS LLC. Units affected: 126 trays.
Why was this product recalled?
Povidone-Iodine swabstick manufactured by PDI, Inc. recalled due to Out of Specifications was used as a component in some of the ROI CPS, LLC products.
Which agency issued this recall?
This recall was issued by the FDA Devices on November 24, 2021. Severity: Moderate. Recall number: Z-0250-2022.