Regard Kit containing the Microtek decanter
- Company
- Roi Cps Llc
- Recall Initiated
- June 17, 2024
- Posted
- August 16, 2024
- Recall Number
- Z-2685-2024
- Quantity
- 78 Kits
- Firm Location
- Republic, MO
Reason for Recall
Decanters may have pin holes and tears in sterile packaging that cannot be identified visually.
Distribution
US Nationwide distribution in the state of MO.
Lot / Code Info
Item Number: 830099009; UDI: 10194717116677; Lot number's 99206 (Expiration Date: 2024-09-15) and 100633 (Expiration Date: 2024-09-15)
Root Cause
Pending
Action Taken
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.