FDAClass IINovember 10, 2021

COVENA PICC Sleeve recall

COVENA PICC Sleeve

Why was COVENA PICC Sleeve recalled?

Marketed without FDA clearance

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

All lots

Product
COVENA PICC Sleeve
Recalling firm
Queen Comfort Products lLC
Quantity
91 units
Distribution
US Nationwide distribution.
Recall date
November 10, 2021
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls