COVENA PICC Sleeve (Queen Comfort) – Unauthorized Marketing (2021)
Product marketed without FDA clearance raises potential regulatory concerns.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
COVENA PICC Sleeve
Brand
Queen Comfort Products lLC
Lot Codes / Batch Numbers
All lots
Products Sold
All lots
Queen Comfort Products lLC is recalling COVENA PICC Sleeve due to Marketed without FDA clearance. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Marketed without FDA clearance
Recommended Action
Per FDA guidance
The firm notified their consignees of the recall through a distributor electronic portal on 08/17/2021. The firm requested return of the product.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026