ROi CPS LLC Regard Kit containing the Microtek decanter Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Regard Kit containing the Microtek decanter
Brand
ROi CPS LLC
Lot Codes / Batch Numbers
Item Number: 830099009, UDI: 10194717116677, Lot number's 99206 (Expiration Date: 2024-09-15) and 100633 (Expiration Date: 2024-09-15)
Products Sold
Item Number: 830099009; UDI: 10194717116677; Lot number's 99206 (Expiration Date: 2024-09-15) and 100633 (Expiration Date: 2024-09-15)
ROi CPS LLC is recalling Regard Kit containing the Microtek decanter due to Decanters may have pin holes and tears in sterile packaging that cannot be identified visually.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Decanters may have pin holes and tears in sterile packaging that cannot be identified visually.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026