FDAFDA · Food and drugs·Recall number Z-0031-2025
Aligned Medical Tonsil Pack REF AMS14809 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
Published October 16, 2024 · Recall initiated: August 16, 2024
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
Due to convenience kits containing a kit component that is under a recall action for improper use.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Windstone Medical Packaging, Inc.
- Distributor
- U.S. Nationwide distribution in the states of CA, MO, OH, VA, and WY.
- Lot
- Catalog Number: AMS14809 UDI-DI code: B098AMS148090 Lot Numbers: 192737 194922 200224 200950 203412
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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