Recall Z-1287-2024— Peter Lazic Gmbh

Name: FDA recall Z-1287-2024
Creator: U.S. Food and Drug Administration
Published: 2023-07-14

Class II · Ongoing

Class II FDA medical device recall by Peter Lazic Gmbh, initiated 2023-07-14. It names one FDA 510(k) clearance: K081489. Product: L-Aneurysm Clip TITANIUM Paddle-Clip, permanent, 11 mm straight, Sterile. Reason: Wrong product coloring. The paddle clips should be blank, but they are colored blue..

Recalling firm: Peter Lazic Gmbh
Classification: Class II
Status: Ongoing
Initiated: 2023-07-14
Firm location: Tuttlingen, N/A, Germany

510(k) clearances named in this recall

1 on FDA's record

K081489 — L-ANEURYSM-CLIP SYSTEM & L-ANEURYSM CLIP APPLIERS, YASARGIL ANEURYSM CLIPS & YASARGIL ANEURYSM CLIP APPLIERSPeter Lazic GmbH·cleared 2008-09-25

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

Wrong product coloring. The paddle clips should be blank, but they are colored blue.

Data sourced from openFDA. This site is unofficial and independent of the FDA.