Recall Z-2685-2024— ROi CPS LLC
Class II · Ongoing
Class II FDA medical device recall by ROi CPS LLC, initiated 2024-06-17. FDA's recall record names no specific 510(k) clearance for this event. Product: Regard Kit containing the Microtek decanter. Reason: Decanters may have pin holes and tears in sterile packaging that cannot be identified visually..
- Recalling firm
- ROi CPS LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-06-17
- Firm location
- Republic, MO, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.