Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Open, Classified

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

FDA Recall Z-1288-2024 · Posted 2024-03-12

Recalling FirmPeter Lazic Gmbh
Recall StatusOpen, Classified
Product CodeHCH
Date Initiated2023-07-14
Product Quantity51 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.

K081489L-ANEURYSM-CLIP SYSTEM & L-ANEURYSM CLIP APPLIERS, YASARGIL ANEURYSM CLIPS & YASARGIL ANEURYSM CLIP APPLIERSPeter Lazic GmbH · 2008-09-25

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑