Z-0187-2022 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- November 10, 2021
- Initiation Date
- August 18, 2021
- Termination Date
- May 6, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 91 units
Product Description
COVENA PICC Sleeve
Reason for Recall
Marketed without FDA clearance
Distribution Pattern
US Nationwide distribution.
Code Information
All lots