FDAFDA · Food and drugs·Recall number Z-1358-2025
MAJOR VASCULAR PACK , Model No UTMV78X-01 UTMV78Y UTMV78Y-01 UTMV78X-01 UTMV78Y-02
Published March 26, 2025 · Recall initiated: February 6, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- American Contract Systems Inc
- Distributor
- US Nationwide distribution in the state of OH.
- Lot
- UDI-DI 00191072205100 00191072217370 Lots 974241 884241 70-051159 70-052011 70-052602 70-053158
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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