Device product

COVENA PICC Sleeve

Z-0187-2022

August 18, 2021

Class II

Product summary

Firm: Queen Comfort Products lLC
Event: Event 88793
Status: Terminated
Classification: Class II
Quantity: 91 units
Official record key: device-enforcement:Z-0187-2022

Official wording

Reason: Marketed without FDA clearance

Code information: All lots

Distribution pattern: US Nationwide distribution.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Marketed without FDA clearance