FDAFDA · Food and drugs·Recall number Z-1079-2024
Aligned Medical Solutions, Local Lower Extremity Pack I, AMS10833, 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
- DI: B098AMS108330/Lot #s: 173719 176590 174338 175529 176217 178271 178489 180907 183355 183674 184398 185064 188137 189007 189640 189641 189642 191067 192551 196380 197727 198046 198373 181439 194252 199297
- 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.