FDA Recall Open, Classified

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

Recall: Z-1287-2024 · Initiated July 14, 2023

Recall

Recall Number
Z-1287-2024
Event Number
93952
Firm
Peter Lazic Gmbh Immelmannweg 2 Tuttlingen Germany
FEI Number
3007264034
Product Code
HCH
Status
Open, Classified
Root Cause
Process control
Initiated
July 14, 2023
Posted
March 12, 2024

Description

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.

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).

Distribution

US Nationwide distribution in the state of ME.

Quantity

170 units