Z-1288-2024Class II

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

Name: Z-1288-2024 L-Aneurysm Clip TITANIUM Paddle-Clip, permanent, 11 mm straight, Non-Sterile
Creator: Peter Lazic Gmbh
Published: 2023-07-14
License: https://open.fda.gov/license/

Peter Lazic GmbH / initiated 2023-07-14 / Open, Classified / root cause: manufacturing process

FDA source

Peter Lazic Gmbh began a recall of L-Aneurysm Clip TITANIUM Paddle-Clip, permanent, 11 mm straight, Non-Sterile on 2023-07-14. FDA classified it as Class II and gives the reason as "Wrong product coloring. The paddle clips should be blank, but they are colored blue". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1288-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-07-14
Posted: 2024-03-12
Recalling firm: Peter Lazic GmbH
Product: L-Aneurysm Clip TITANIUM Paddle-Clip, permanent, 11 mm straight, Non-Sterile
Product code: HCH Clip, Aneurysm
Reason for recall: Wrong product coloring. The paddle clips should be blank, but they are colored blue.
Root cause tag: manufacturing process
FDA 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 ([email protected]/+49 (0) 7461 96643-20 or [email protected]/+49 (0) 7461 96643-21).
Quantity in commerce: 51 units
Distribution: US Nationwide distribution in the state of ME.
Product codes and lots: Model Number: 45.782; UDI/DI: 04250603733799; Serial Numbers: LX61385, LW36020, LW36021, LW36022, LW36023, LW36024, LW36025, LW36026, LW36027;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1288-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1287-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-20	2024-03-12
Z-1288-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-20	2024-03-12

Product code HCH

K081489Class IIL-Aneurysm-Clip System & L-Aneurysm Clip Appliers, Yasargil Aneurysm Clips & Yasargil Aneurysm Clip AppliersPeter Lazic GmbH / cleared 2008-09-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)