The Recall Desk
LowFDA (Devices)·Z-1288-2024·Announced 2024-03-20

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.

What this means for you

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
  • cosmetic-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 (11)

  • Model Number: 45.782
  • UDI/DI: 04250603733799
  • Serial Numbers: LX61385
  • LW36020
  • LW36021
  • LW36022
  • LW36023
  • LW36024
  • LW36025
  • LW36026
  • LW36027

Distribution

Distributed nationwide across the United States.