Queen Comfort Products lLC: Medical Device Recall in 2021 - (Recall #: Z-0187-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

COVENA PICC Sleeve

Product Classification:

Class II

Date Initiated: August 18, 2021

Date Posted: November 10, 2021

Recall Number: Z-0187-2022

Event ID: 88793

Reason for Recall:

Marketed without FDA clearance

Status: Terminated

Product Quantity: 91 units

Code Information:

All lots

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated