Recall Z-2465-2020 ยท OEA Non-Surgical Gown
ROi CPS LLC
Isolation Droplet Bundle Kit
| Date | May 19, 2020 |
| Status | Terminated |
| Reason | Roi CPS, LLC has become aware of a labeling error that affects select custom procedure kits. The kits are labeled with an expiration date that is later than that of the soonest kit component to expire in the kits. |
| Root cause | Error in labeling |
| Action | On May 19, 2020 Roi CPS LLC notified its customers to review their inventory to determine if the custom procedure kit item and lot identified were on their inventory. If identified, please quarantine and notify Roi of the quantity on hand completing the reply form provided to them via email and to forward this notification to all potential user of the recall. |
| Quantity | 24 kits |
| Distribution | Domestic distribution only to: MO and LA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.