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L-Aneurysm Clip TITANIUM Paddle-Clip, permanent, 11 mm… recallZ-1287-2024 · Peter Lazic Gmbh · initiated Jul 14, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Peter Lazic Gmbh or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Process control

What the company is doing

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 ([email protected]/+49 (0) 7461 96643-20 or [email protected]/+49 (0) 7461 96643-21).

Recall details

Recall number
Z-1287-2024
Status
Open, Classified
Initiated by the company
Jul 14, 2023
Posted by the FDA
Mar 12, 2024
Recalling firm
Peter Lazic Gmbh
Quantity
170 units
Product code
HCH
FDA submissions
K081489
Distribution
US Nationwide distribution in the state of ME.

Product description

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

Code information (models, lots, serial numbers)

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;

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 93952).

Sources and updates

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