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.
Marketed without FDA clearance
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.
The COVENA PICC Sleeves were marketed without FDA clearance, meaning they were not tested or approved for safety and effectiveness before being sold. This could lead to health risks if used without proper medical oversight.
Patients using PICC sleeves for medical treatments may be affected. Healthcare providers who use these sleeves without FDA clearance are at risk.
All COVENA PICC Sleeves are affected. The product is sold by Queen Comfort Products LLC.
Look for the product name and manufacturer on the sleeve packaging.
The COVENA PICC Sleeves were marketed without FDA clearance, meaning they were not tested or approved for safety and effectiveness.
All COVENA PICC Sleeves are affected, and the product is sold by Queen Comfort Products LLC.
The recall record does not specify a remedy, so the official notice does not provide action steps.
We’ve drafted a message you can send Queen Comfort to request your refund or repair — edit it as you like.
Subject: Recall Z-0187-2022 — Queen Comfort Queen Comfort Hello, I own a Queen Comfort that is covered by recall Z-0187-2022 from Queen Comfort. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
