L-Aneurysm Clip TITANIUM Paddle-Clip, permanent, 11 mm straight, Non-Sterile
FDA device recall Z-1288-2024 · posted 2024-03-12 · Open, Classified
Recall details
- Recalling firm
- Peter Lazic Gmbh
- Reason for recall
- Wrong product coloring. The paddle clips should be blank, but they are colored blue.
- Action taken
- 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).
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- HCH
- Quantity affected
- 51 units
- Distribution
- US Nationwide distribution in the state of ME.
- Date initiated
- 2023-07-14
- Date posted
- 2024-03-12
- Location
- Tuttlingen, Germany
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| L-ANEURYSM-CLIP SYSTEM & L-ANEURYSM CLIP APPLIERS, YASARGIL ANEURYSM CLIPS & YASARGIL ANEURYSM CLIP APPLIERS (K081489) | Peter Lazic GmbH | 2008-09-25 |