Recall Z-1288-2024 ยท HCH Clip, Aneurysm
Peter Lazic Gmbh
L-Aneurysm Clip TITANIUM Paddle-Clip, permanent, 11 mm straight, Non-Sterile
| Date | Mar 12, 2024 (initiated Jul 14, 2023) |
| Status | Open, Classified |
| Reason | Wrong product coloring. The paddle clips should be blank, but they are colored blue. |
| Root cause | 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 | 51 units |
| Distribution | US Nationwide distribution in the state of ME. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081489 | L-ANEURYSM-CLIP SYSTEM & L-ANEURYSM CLIP APPLIERS, YASARGIL ANEURYSM CLIPS & YASARGIL ANEURYSM CLIP APPLIERS Peter Lazic GmbH, Sep 25, 2008 |