L-Aneurysm Clip TITANIUM Paddle-Clip, permanent, 11 mm straight, Sterile
This recall is currently active, issued March 12, 2024. It was issued by Peter Lazic Gmbh Immelmannweg 2 Tuttlingen Germany.
- Recall Initiated
- July 14, 2023
- Posted
- March 12, 2024
- Recall Number
- Z-1287-2024
- Quantity
- 170 units
- Official Source
- View on FDA website ↗
Reason for Recall
Wrong product coloring. The paddle clips should be blank, but they are colored blue.
Distribution
US Nationwide distribution in the state of ME.
Lot / 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;
Root Cause
Process control
Action Taken
Scripted Phone calls were made to customers on July 14, 2023. The customers were provided information on how to identify affected product and to return all product subject to recall and to notify any of their customers as well. Instructions for return were provided. Updated 3/11/24: Customer notification letters sent out on March 5, 2024 to summarize the information from the phone calls. Customers were instructed to inspect their inventory and return all stock products to one of the PRRCs (info@lazic.de/+49 (0) 7461 96643-20 or k.maier@lazic.de/+49 (0) 7461 96643-21).