COVENA PICC Sleeve Recalled for Unauthorized FDA Marketing
Queen Comfort Products is recalling the COVENA PICC Sleeve, marketed without FDA clearance. Patients currently using the device should contact their healthcare provider immediately.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The COVENA PICC Sleeve is a medical device marketed without FDA clearance. Although no illnesses or injuries are reported, this represents a risk-of-harm product that has not been evaluated for safety and effectiveness, meeting the rubric criterion for Score 3.
Plain-English summary
Queen Comfort Products LLC is recalling the COVENA PICC Sleeve because it was marketed without FDA clearance. A PICC sleeve is a medical device used in healthcare settings.
The device was distributed nationwide across the United States. All lots are affected in this recall, with 91 units involved.
Because this device was marketed without the required FDA authorization, it has not been reviewed for safety and effectiveness. Patients who are currently using a COVENA PICC Sleeve should contact their healthcare provider or Queen Comfort Products immediately for guidance on next steps. Healthcare providers should review their inventory and patient records to identify any affected devices.
The recalled product
- Product
- COVENA PICC Sleeve
- Manufacturer
- Queen Comfort Products lLC
- Category
- Medical Device — Vascular Access
- Affected units
- 91
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lots
Distribution
Distributed nationwide across the United States.
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