FDA Enforcement
Class II
Ongoing
L-Aneurysm Clip TITANIUM Paddle-Clip, permanent, 11 mm straight, Non-Sterile
Recall: Z-1288-2024
·
Reported March 20, 2024
Enforcement
- Recall Number
- Z-1288-2024
- Event ID
- 93952
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Peter Lazic Gmbh
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Telephone
- Report Date
- March 20, 2024
- Initiation Date
- July 14, 2023
- Classification Date
- March 12, 2024
- Address
- Immelmannweg 2, N/A, Tuttlingen, N/A, N/A, Germany
Description
L-Aneurysm Clip TITANIUM Paddle-Clip, permanent, 11 mm straight, Non-Sterile
Reason
Wrong product coloring. The paddle clips should be blank, but they are colored blue.
Code Info
Model Number: 45.782; UDI/DI: 04250603733799; Serial Numbers: LX61385, LW36020, LW36021, LW36022, LW36023, LW36024, LW36025, LW36026, LW36027;
Distribution
US Nationwide distribution in the state of ME.
Quantity
51 units