FDAFDA · Food and drugs·Recall number Z-1339-2025
OPEN HEART ADULT - SIDE A , Model Nos LLOH01I-01 LLOH01I
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 00191072219251 Lots 898241 70-050704 70-051731
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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