COVENA PICC Sleeve — Class II medical device recall Z-0187-2022
Terminated recall by Queen Comfort Products lLC, reported 2021-11-10, distributed nationwide. Marketed without FDA clearance
| Recall number | Z-0187-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Queen Comfort Products lLC, Waxhaw, NC, United States |
| Recall initiated | 2021-08-18 |
| Classified | 2021-11-01 |
| Reported by FDA | 2021-11-10 |
| Terminated | 2024-05-06 |
| Distributed | Nationwide (US) |
| Quantity | 91 units |
Product
COVENA PICC Sleeve
Reason for recall
Marketed without FDA clearance
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0187-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.