FDA Device recall Z-0187-2022
COVENA PICC Sleeve
- FDA Device
- Class II
- terminated
- Published 2021-11-10
On 2021-11-10 the FDA classified a Class II recall of COVENA PICC Sleeve by Queen Comfort Products, citing marketed without FDA clearance.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0187-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-08-18 |
| Published | 2021-11-10 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Queen Comfort Products |
| Distribution | US |
Product
COVENA PICC Sleeve
Reason
Marketed without FDA clearance
Identifiers
| code_info | All lots |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0187-2022%22
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