L-Aneurysm Clip TITANIUM Paddle-Clip, permanent, 11 mm straight, Sterile
FDA Recall Z-1287-2024 · Posted 2024-03-12
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Recalling FirmPeter Lazic Gmbh
Recall StatusOpen, Classified
Product CodeHCH
Date Initiated2023-07-14
Product Quantity170 units
Reason for Recall
Wrong product coloring. The paddle clips should be blank, but they are colored blue.
Firm 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 ([email protected]/+49 (0) 7461 96643-20 or [email protected]/+49 (0) 7461 96643-21).
Root Cause
Process control
Distribution Pattern
US Nationwide distribution in the state of ME.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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