| Class 2 Device Recall Paddle Clip LAneurysmClip System | |
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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = HCH
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