FDA Recall
Open, Classified
Regard Kit containing the Microtek decanter
Recall: Z-2685-2024
·
Initiated June 17, 2024
Recall
- Recall Number
- Z-2685-2024
- Event Number
- 94999
- Firm
- ROi CPS LLC
- FEI Number
- 3014527682
- Product Code
- KPE
- Status
- Open, Classified
- Root Cause
- Pending
- Initiated
- June 17, 2024
- Posted
- August 16, 2024
- Address
- 3000 E Sawyer Rd, Republic, MO, 65738-2758
Description
Regard Kit containing the Microtek decanter
Reason
Decanters may have pin holes and tears in sterile packaging that cannot be identified visually.
Action
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.
Distribution
US Nationwide distribution in the state of MO.
Quantity
78 Kits