FDAClass IINovember 24, 2021

REGARD Newborn Tray recall

REGARD Newborn Tray

Why was REGARD Newborn Tray 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot number: 86453F

Product
REGARD Newborn Tray
Recalling firm
ROi CPS LLC
Quantity
12
Distribution
US Nationwide in the states of FL, LA and MO.
Recall date
November 24, 2021
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls