FDA-Device2021-11-24Class II
REGARD Ear Tray
ROi CPS LLC
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.
Sold states
US Nationwide in the states of FL, LA and MO.
Affected count
44 trays
Manufactured in
3000 E Sawyer Rd, N/A, Republic, MO, United States
Products
REGARD Ear Tray
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0252-2022Don't want to check this manually?
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