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U.S. Department of Health and Human Services

Class 2 Device Recall Paddle Clip LAneurysmClip System

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  Class 2 Device Recall Paddle Clip LAneurysmClip System see related information
Date Initiated by Firm July 14, 2023
Date Posted March 12, 2024
Recall Status1 Open3, Classified
Recall Number Z-1288-2024
Recall Event ID 93952
510(K)Number K081489  
Product Classification Clip, aneurysm - Product Code HCH
Product L-Aneurysm Clip TITANIUM Paddle-Clip, permanent, 11 mm straight, Non-Sterile
Code Information Model Number: 45.782; UDI/DI: 04250603733799; Serial Numbers: LX61385, LW36020, LW36021, LW36022, LW36023, LW36024, LW36025, LW36026, LW36027;
Recalling Firm/
Manufacturer		 Peter Lazic Gmbh
Immelmannweg 2
Tuttlingen Germany
For Additional Information Contact Customer Support
7461 96643 20
Manufacturer Reason
for Recall		 Wrong product coloring. The paddle clips should be blank, but they are colored blue.
FDA Determined
Cause 2		 Process control
Action 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).
Quantity in Commerce 51 units
Distribution US Nationwide distribution in the state of ME.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = HCH and Original Applicant = PETER LAZIC GMBH
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