Recall Z-0596-2024 ยท OXQ Dressing Change Tray
ROi CPS LLC
Regard Dressing change kit, Item Number 800026006
| Date | Jan 3, 2024 (initiated Nov 20, 2023) |
| Status | Terminated |
| Reason | ROi CPS manufactured and distributed medical convenience kits with an irrigation solution component which was subsequently recalled by the component manufacturer. |
| Root cause | Nonconforming Material/Component |
| Action | ROi CPS issued an URGENT MEDICAL DEVICE CORRECTION NOTICE to its sole consignee on 11/27/2023 via email. The notice explained the problem, potential risk, and requested the following actions: 1. CHECK: Please review your inventory to determine if the manufacturer item number and lot numbers listed in the above table are in your inventory. 2. QUARANTINE: Segregate and quarantine all affected kits listed above. Do not further distribute. 3. REMOVE: The affected Cardinal Health item 1022-(100ML Sterile Saline Irrigation bottle), attached to the outside of the affected kits as a piggy back pri |
| Quantity | 1830 units |
| Distribution | US Nationwide distribution in the state of Louisiana. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.