FDAFDA · Food and drugs·Recall number Z-1354-2025
DIAGNOSTIC NEURO IR TRAY , Model No WENE21
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 00191072212900 00191072218001 Lots 960241 71-050727 71-051234 71-051771 71-052322 71-052501 71-052705
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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