The Recall Desk
ModerateFDA (Devices)·Z-1287-2024·Announced 2024-03-20

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.

What this means for you

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
  • coloring-defect

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

Distributed nationwide across the United States.