FDA Enforcement
Class II
Ongoing
Microscissor Tip (Disposable); Microline Catalog #: 3122.
Recall: Z-0663-2025
·
Reported December 18, 2024
Enforcement
- Recall Number
- Z-0663-2025
- Event ID
- 95734
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Microline Surgical, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 18, 2024
- Initiation Date
- November 5, 2024
- Classification Date
- December 10, 2024
- Address
- 50 Dunham Rd Ste 1500, Beverly, MA, 01915-1882, United States
Description
Microscissor Tip (Disposable); Microline Catalog #: 3122.
Reason
A lot of ReNew Microscissor Tips exhibited a 2% rate of failure in terms of the heat shrink breaking off.
Code Info
Microline Catalog #: 3122; UDI/DI: 811099010036; Lot Number: 00172110.
Distribution
Worldwide - US Nationwide in the state of OK and the country of Japan.
Quantity
200 units