FDAClass IIAugust 28, 2024

Regard Kit containing the Microtek decanter recall

Regard Kit containing the Microtek decanter

Why was Regard Kit containing the Microtek decanter recalled?

Decanters may have pin holes and tears in sterile packaging that cannot be identified visually.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA 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?

Item Number: 830099009; UDI: 10194717116677; Lot number's 99206 (Expiration Date: 2024-09-15) and 100633 (Expiration Date: 2024-09-15)

Product
Regard Kit containing the Microtek decanter
Recalling firm
ROi CPS LLC
Quantity
78 Kits
Distribution
US Nationwide distribution in the state of MO.
Recall date
August 28, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls