Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

COVENA PICC Sleeve Recalled by Queen Comfort Products lLC Due to Marketed without FDA clearance

Date: August 18, 2021
Company: Queen Comfort Products lLC
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Queen Comfort Products lLC directly.

Affected Products

COVENA PICC Sleeve

Quantity: 91 units

Why Was This Recalled?

Marketed without FDA clearance

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Queen Comfort Products lLC

Queen Comfort Products lLC has 1 total recall tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report