Recall Z-1542-2021 ยท OXQ Dressing Change Tray
ROi CPS LLC
Regard Dressing Change Tray
| Date | Mar 26, 2021 |
| Status | Terminated |
| Reason | ChloraPrep applicators in the kit can grow organisms that can result in a breach of the applicators package integrity. |
| Root cause | Package design/selection |
| Action | On March 26, 2021 the firm sent a notification to customers: Actions to be taken by customers: 1. CHECK: please review your inventory to determine if the manufacturer item numbers and lot numbers listed in the above table are in your inventory. 2. ACT: If the affected kits are identified, immediately quarantine. Use the attached Avery label template to label the affected kits. Place the label in a location where it is clearly visible. The label instructs the end user to remove the ChloraPrep from the kit and pull from sterile supply. 3. REPLY: Please complete the attached reply form indicati |
| Quantity | 272 trays |
| 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.