Recall Z-0187-2022— Queen Comfort Products lLC
Class II · Terminated
Class II FDA medical device recall by Queen Comfort Products lLC, initiated 2021-08-18, terminated 2024-05-06. FDA's recall record names no specific 510(k) clearance for this event. Product: COVENA PICC Sleeve. Reason: Marketed without FDA clearance.
- Recalling firm
- Queen Comfort Products lLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-08-18
- Terminated
- 2024-05-06
- Firm location
- Waxhaw, NC, United States
Product description
COVENA PICC Sleeve
Reason for recall
Marketed without FDA clearance
Data sourced from openFDA. This site is unofficial and independent of the FDA.