Device product
Regard Kit containing the Microtek decanter
Z-2685-2024
Product summary
- Firm
- ROi CPS LLC
- Event
- Event 94999
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 78 Kits
- Official record key
device-enforcement:Z-2685-2024
Official wording
Reason: Decanters may have pin holes and tears in sterile packaging that cannot be identified visually.
Code information: Item Number: 830099009; UDI: 10194717116677; Lot number's 99206 (Expiration Date: 2024-09-15) and 100633 (Expiration Date: 2024-09-15)
Distribution pattern: US Nationwide distribution in the state of MO.
Derived failure modes
-
Unknown
Decanters may have pin holes and tears in sterile packaging that cannot be identified visually.