FDAFDA · Food and drugs·Recall number Z-1080-2024
Aligned Medical Solutions, In House Ocular Pack, AMS12947A STERILEEO
Published February 28, 2024 · Recall initiated: December 22, 2023
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
Sterility assurance for saline included in surgical kits cannot be guaranteed.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Windstone Medical Packaging, Inc.
- Distributor
- US: FL, IL, CA OUS: None
- Lot
- UDI: B098AMS12947A0/Lot #s: 192436, 192774, 196582
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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