Summary
The FDA issued a Class II for COVENA PICC Sleeve by Queen Comfort Products lLC. Reason: Marketed without FDA clearance.
Details
Source
Device Recall
External ID
Z-0187-2022
Action Date
2021-11-10
Status
Terminated
Category
device
Product Description
COVENA PICC Sleeve
Lot/Code Info: All lots
Quantity Affected: 91 units
Reason for Recall
Marketed without FDA clearance
Distribution
US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-08-18
Company
Waxhaw, NC
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 120 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Queen Comfort Products lLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Queen Comfort Products lLC have FDA actions?
This is the only FDA action we have on record for Queen Comfort Products lLC in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0187-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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