Date Initiated by Firm |
August 18, 2021 |
Create Date |
November 01, 2021 |
Recall Status1 |
Completed |
Recall Number |
Z-0187-2022 |
Recall Event ID |
88793 |
Product Classification |
Restraint, protective - Product Code FMQ
|
Product |
COVENA PICC Sleeve |
Code Information |
All lots |
Recalling Firm/ Manufacturer |
Queen Comfort Products lLC 8517 Chatsworth Ln Waxhaw NC 28173-6523
|
For Additional Information Contact |
Sean Wagner 704-705-7358
|
Manufacturer Reason for Recall |
Marketed without FDA clearance
|
FDA Determined Cause 2 |
Process control |
Action |
The 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 Commerce |
91 units |
Distribution |
US Nationwide distribution. |
Total Product Life Cycle |
TPLC Device Report
|
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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.
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