FDAFDA · Food and drugs·Recall number Z-2524-2024
American Contract Systems Spine Pack convenience kit
Published August 14, 2024 · Recall initiated: May 6, 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
Product released with insufficient aeration time impacting the kits sterilized on the same cycle or in the same aeration chamber
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- American Contract Systems, Inc.
- Distributor
- US Nationwide distribution in the states of CA, KS, ME, MN, MO, NE, and SD.
- Lot
- UDI-DI 00191072202499; Lot 980241; Exp. Date 1/10/2025.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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