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U.S. Department of Health and Human Services

Class 2 Device Recall COVENA PICC Sleeve

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 Class 2 Device Recall COVENA PICC Sleevesee related information
Date Initiated by FirmAugust 18, 2021
Create DateNovember 01, 2021
Recall Status1 Terminated 3 on May 06, 2024
Recall NumberZ-0187-2022
Recall Event ID 88793
Product Classification Restraint, protective - Product Code FMQ
ProductCOVENA PICC Sleeve
Code Information All lots
FEI Number 3018939295
Recalling Firm/
Manufacturer		 Queen Comfort Products lLC
8517 Chatsworth Ln
Waxhaw NC 28173-6523
For Additional Information ContactSean Wagner
704-705-7358
Manufacturer Reason
for Recall		Marketed without FDA clearance
FDA Determined
Cause 2		Process control
ActionThe firm notified their consignees of the recall through a distributor electronic portal on 08/17/2021. The firm requested return of the product.
Quantity in Commerce91 units
DistributionUS Nationwide distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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