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Recall Observatory FDA recall evidence

Device product

MAJOR VASCULAR PACK , Model No UTMV78X-01 UTMV78Y UTMV78Y-01 UTMV78X-01 UTMV78Y-02

Z-1358-2025

February 06, 2025

Class II

Product summary

Firm
American Contract Systems Inc
Event
Event 96343
Status
Ongoing
Classification
Class II
Quantity
147 kits
Official record key
device-enforcement:Z-1358-2025

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 00191072205100 00191072217370 Lots 974241 884241 70-051159 70-052011 70-052602 70-053158

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.