Unrated Medical device recall · FDA · Published August 18, 2021

Queen Comfort COVENA PICC Sleeve Recall: FDA Clearance Issue

Queen Comfort recalls all COVENA PICC Sleeves due to being marketed without FDA clearance. This may pose health risks if used without proper medical oversight.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0187-2022Medical device Queen Comfort ›

Recall notice

Marketed without FDA clearance

Take action

Contact the company

Recalling firmQueen Comfort Products lLC8517 Chatsworth Ln · Waxhaw, NC 28173-6523

✎ GovInfoNow plain-language explainer

Queen Comfort is recalling all COVENA PICC Sleeves because they were sold without FDA clearance. This could lead to health risks if used without proper medical supervision. Read more at govinfonow.com/recall/61928-queen-comfort-covena-picc-sleeve-recall-fda-clearance-issue.

Source Summary by GovInfoNow · govinfonow.com/recall/61928-queen-comfort-covena-picc-sleeve-recall-fda-clearance-issue · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0187-2022

Cite this page

“Queen Comfort COVENA PICC Sleeve Recall: FDA Clearance Issue.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61928-queen-comfort-covena-picc-sleeve-recall-fda-clearance-issue. Based on FDA recall #Z-0187-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0187-2022%22&limit=1).

Queen Comfort Products LLC recalled the COVENA PICC Sleeve because it was marketed without FDA clearance, the Food and Drug Administration said on Aug. 18, 2021. The agency announced the voluntary Class II recall affecting all lots of the device.

How to tell if you have it

Brand: Queen Comfort
Product: COVENA PICC Sleeve
Lots: All lots
Quantity: 91 units
Distribution: US Nationwide

The hazard

The COVENA PICC Sleeve was marketed without FDA clearance, according to the FDA. The recall is classified as Class II.

Context

GovInfoNow's records show other recent recalls of similar products include Medline PICC Tray DYNJ41648A (2026-02-25), QUCARE Total Cholesterol Test (2026-04-02) and Medline Convenience Kits with Unapproved Syringes (2026-02-27).

How to tell if you have this one

All COVENA PICC Sleeves are affected. The product is sold by Queen Comfort Products LLC.

Brand
Queen Comfort
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Look for the product name and manufacturer on the sleeve packaging.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 2.7 years after the firm started it.

Aug 18, 2021Firm started the recall
Nov 1, 2021FDA classified it Class II
Nov 10, 2021Published in FDA’s Enforcement Report
May 6, 2024FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

Similar recalls

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Keep exploring

More Queen Comfort recalls

Link to this recall

<a href="https://govinfonow.com/recall/61928-queen-comfort-covena-picc-sleeve-recall-fda-clearance-issue">Queen Comfort COVENA PICC Sleeve Recall: FDA Clearance Issue (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0187-2022 (August 18, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0187-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.