Aneurysm clips recalled due to incorrect blue coloring
Peter Lazic Gmbh is recalling 170 L-Aneurysm Clip TITANIUM Paddle-Clips distributed in Maine due to incorrect blue coloring instead of 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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall with a manufacturing defect affecting product appearance. No reported illnesses, injuries, or hospitalizations. The coloring error is a quality control issue with no documented clinical harm.
Plain-English summary
Peter Lazic Gmbh is recalling 170 units of L-Aneurysm Clip TITANIUM Paddle-Clip (permanent, 11 mm straight, sterile) due to a manufacturing defect. The clips were manufactured with blue coloring when they should be blank per product specifications.
The recalled units (Model S.45.782, UDI/DI 04250603734697) were distributed in Maine and are identified by 54 specific serial numbers including LX61400, LX61401, LX63366, LX63368–LX63375, LX65981–LX65984, LX66073–LX66075, LX61372–LX61395, LW50566–LW50568, and LX72845–LX72854.
Healthcare facilities that have received these clips should not use affected units and should contact Peter Lazic Gmbh for replacement or additional guidance. No illnesses or injuries have been reported related to this defect.
The recalled product
- Product
- L-Aneurysm Clip TITANIUM Paddle-Clip, permanent, 11 mm straight, Sterile
- Manufacturer
- Peter Lazic Gmbh
- Hazard
- Affected units
- 170
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 (20)
- Model Number: S.45.782
- UDI/DI: 04250603734697
- Serial Numbers: LX61400
- LX61401
- LX63366
- LX63368
- LX63369
- LX63370
- LX63371
- LX63372
- LX63373
- LX63374
- LX63375
- LX65981
- LX65982
- LX65983
- LX65984
- LX66073
- LX66074
- LX66075
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
Same manufacturer · Peter Lazic Gmbh
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