Recall Z-2685-2024
ROi CPS LLC · initiated June 17, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Regard Kit containing the Microtek decanter
Codes / lots: Item Number: 830099009; UDI: 10194717116677; Lot number's 99206 (Expiration Date: 2024-09-15) and 100633 (Expiration Date: 2024-09-15)
Reason for recall
Decanters may have pin holes and tears in sterile packaging that cannot be identified visually.
FDA-determined 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.
Details
- Recall number
- Z-2685-2024
- Initiated
- June 17, 2024
- Posted by FDA
- August 16, 2024
- Product code
- KPE – Container, I.V.
- Quantity
- 78 Kits
- Distribution
- US Nationwide distribution in the state of MO.
- Recalling firm
- ROi CPS LLC, Republic, MO