FDAFDA · Food and drugs·Recall number Z-2520-2024
American Contract Systems Special Procedure 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, which may have been compromised in sterility
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
- (1) Model No SLSP77G; UDI-DI 00191072198730; Lot 981241; Exp. Date 1/19/2025; (2) Model No EJAG58A; UDI-DI 00191072190093; Lot 982241; Exp. Date 1/18/2025.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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