FDAFDA · Food and drugs·Recall number Z-1082-2024
Aligned Medical Solutions, Closure Kit, AMS13043, 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: B098AMS130430/Lot #s: 178114 187325 191102 195504 196502 197864
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.