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Recall Observatory FDA recall evidence

Device product

L-Aneurysm Clip TITANIUM Paddle-Clip, permanent, 11 mm straight, Non-Sterile

Z-1288-2024

July 14, 2023

Class II

Product summary

Firm
Peter Lazic Gmbh
Event
Event 93952
Status
Ongoing
Classification
Class II
Quantity
51 units
Official record key
device-enforcement:Z-1288-2024

Official wording

Reason: Wrong product coloring. The paddle clips should be blank, but they are colored blue.

Code information: Model Number: 45.782; UDI/DI: 04250603733799; Serial Numbers: LX61385, LW36020, LW36021, LW36022, LW36023, LW36024, LW36025, LW36026, LW36027;

Distribution pattern: US Nationwide distribution in the state of ME.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Wrong product coloring. The paddle clips should be blank, but they are colored blue.