Regard Kit containing the Microtek decanter

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

The distributor was notified of the recall via letter emailed on 06/17/2024. The distributor was instructed to review their inventory to determine if the item listed in the letter is in the inventory; complete and return a response form, notify any customers to whom the product was distributed, end users should immediately quarantine any affected kits at their facility and discontinue use, and report any adverse health consequences experienced with the product to FDA.