Recall Z-0469-2022 ยท OGR Ear, Nose, And Throat Surgical Tray
ROi CPS LLC
Regard, T AND A - Rogers, sterilized convenience kits
| Date | Nov 30, 2021 |
| Status | Terminated |
| Reason | Kits lacks rubber latex warning label. |
| Root cause | Error in labeling |
| Action | A customer notification email dated 11/30/2021 was sent with recall instructions as follows: 1. Check: Please review your inventory to determine if the manufacturer item numbers and lot numbers listed in the table are in your inventory. 2. Quarantine: If the affected kits are identified, please quarantine the product and do not further distribute. 3. Label Affected kits: Use the label template attached to this notice to label affected kits in your inventory prior to shipping to customers. The label includes the statement "This kit contains a URETHRAL CATHETER RED RUBBER 12FR that contains |
| Quantity | 195 kits |
| Distribution | US Nationwide distribution in the state of MO. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.