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FDAFDA · Food and drugs·Recall number Z-0256-2022

REGARD Vitrectomy Tray

Published November 24, 2021 · Recall initiated: August 10, 2021

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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.

What to do

Voluntary: Firm initiated · E-Mail

Recall details

Manufacturer
ROi CPS LLC
Distributor
US Nationwide in the states of FL, LA and MO.
Lot
Lots numbers: 89042C and 85120B
Risk classification
Class II
Area (FDA)
device
Country
United States

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