Recall Z-0187-2022 ยท FMQ Restraint, Protective
Queen Comfort Products lLC
COVENA PICC Sleeve
| Date | Aug 18, 2021 |
| Status | Terminated |
| Reason | Marketed without FDA clearance |
| Root cause | Process control |
| Action | The firm notified their consignees of the recall through a distributor electronic portal on 08/17/2021. The firm requested return of the product. |
| Quantity | 91 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.