Device product
Mesh Style Tip Protectors CSW-03-2.0 Open-end style CSW-04-4.0 Closed-end style
Z-1943-2026
Product summary
- Event
- Event 98627
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 4,291,797
- Official record key
device-enforcement:Z-1943-2026
Official wording
Reason: Product does not have FDA clearance.
Code information: No UDI. All lots affected.
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
Product does not have FDA clearance.