Skip to content
Recall Observatory FDA recall evidence

Device product

GENERAL ANGIO PACK , Model Nos LLAP75G LLAP75G-01 LLAP75G-02 LLAP75G-03

Z-1340-2025

February 06, 2025

Class II

Product summary

Firm
American Contract Systems Inc
Event
Event 96343
Status
Ongoing
Classification
Class II
Quantity
956 kits
Official record key
device-enforcement:Z-1340-2025

Official wording

Reason: ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.

Code information: UDI-DI 00191072219510 Lots 70-050850 70-051285 70-051779 70-051779A 70-052186 70-052669 70-053022

Distribution pattern: US Nationwide distribution in the state of OH.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.