Z-2685-2024 Class II Ongoing
FDA device recall Z-2685-2024 was initiated by ROi CPS LLC on June 17, 2024 and is designated Class II. Reason for recall: Decanters may have pin holes and tears in sterile packaging that cannot be identified visually. The recall status is ongoing. Affected quantity: 78 Kits.
Recall Details
- Product Type
- Devices
- Report Date
- August 28, 2024
- Initiation Date
- June 17, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 78 Kits
Product Description
Regard Kit containing the Microtek decanter
Reason for Recall
Decanters may have pin holes and tears in sterile packaging that cannot be identified visually.
Distribution Pattern
US Nationwide distribution in the state of MO.
Code Information
Item Number: 830099009; UDI: 10194717116677; Lot number's 99206 (Expiration Date: 2024-09-15) and 100633 (Expiration Date: 2024-09-15)