FDA Enforcement Class II Ongoing

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

Recall: Z-1287-2024 · Reported March 20, 2024

Enforcement

Recall Number
Z-1287-2024
Event ID
93952
Classification
Class II
Status
Ongoing
Product Type
Devices
Firm
Peter Lazic Gmbh
Voluntary / Mandated
Voluntary: Firm initiated
Initial Notification
Telephone
Report Date
March 20, 2024
Initiation Date
July 14, 2023
Classification Date
March 12, 2024
Address
Immelmannweg 2, N/A, Tuttlingen, N/A, N/A, Germany

Description

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

Reason

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

Code Info

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, LX61372, LX61373, LX61374, LX61375, LX61376, LX61377, LX61378, LX61379, LX61380, LX61381, LX61382, LX61383, LX61384, LX61385, LX61386, LX61387, LX61388, LX61389, LX61389, LX61390, LX61391, LX61392, LX61393, LX61394, LX61395, LW50566, LW50567, LW50568, LX72845, LX72846, LX72847, LX72848, LX72849, LX72850, LX72851, LX72852, LX72853, LX72854;

Distribution

US Nationwide distribution in the state of ME.

Quantity

170 units