Aneurysm clips recalled due to incorrect paddle coloring
Peter Lazic Gmbh is recalling 51 titanium aneurysm clip paddle clips because the clips are colored blue when they should be blank.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: This is a cosmetic coloring defect with no reported injuries or functional impact on device performance. Per the severity rubric, cosmetic defects are classified as Low severity.
Plain-English summary
Peter Lazic Gmbh is recalling a total of 51 L-Aneurysm Clip TITANIUM Paddle-Clip units (Model 45.782) because the paddle clips are colored blue when they should be blank. This is a coloring defect in the non-sterile titanium clips used for aneurysm repair procedures.
The recalled clips were distributed nationwide in Maine. The affected units include those with serial numbers LX61385, LW36020, LW36021, LW36022, LW36023, LW36024, LW36025, LW36026, and LW36027. The UDI/DI is 04250603733799.
Healthcare providers who have received these clips should stop using them and contact Peter Lazic Gmbh for a replacement. For more information about this recall, refer to FDA Recall Number Z-1288-2024.
The recalled product
- Product
- L-Aneurysm Clip TITANIUM Paddle-Clip, permanent, 11 mm straight, Non-Sterile
- Manufacturer
- Peter Lazic Gmbh
- Hazard
- Affected units
- 51
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (11)
- Model Number: 45.782
- UDI/DI: 04250603733799
- Serial Numbers: LX61385
- LW36020
- LW36021
- LW36022
- LW36023
- LW36024
- LW36025
- LW36026
- LW36027
Distribution
Part of a larger recall action
This product is one of 2 recalled by Peter Lazic Gmbh under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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