Terminated Class II Medical devices
- Recall started
- 18 August 2021
- Terminated
- 6 May 2024
- Reason
- Marketed without FDA clearance
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0187-2022
- COVENA PICC Sleeve
Waxhaw, NC, United States
Queen Comfort Products lLC recalls
1 recall recorded since 2018, most recently on 18 August 2021. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.