Recall Z-0254-2022— ROi CPS LLC

Name: FDA recall Z-0254-2022
Creator: U.S. Food and Drug Administration
Published: 2021-08-10

Class II · Terminated

Class II FDA medical device recall by ROi CPS LLC, initiated 2021-08-10, terminated 2023-06-16. FDA's recall record names no specific 510(k) clearance for this event. Product: REGARD Stereotactic Tray. Reason: 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..

Recalling firm: ROi CPS LLC
Classification: Class II
Status: Terminated
Initiated: 2021-08-10
Terminated: 2023-06-16
Firm location: Republic, MO, United States

Product description

REGARD Stereotactic 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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.