FDAFDA · Food and drugs·Recall number Z-3241-2024
ENT, COEN27N; Medical convenience kit
Published October 2, 2024 · Recall initiated: August 7, 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
ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- American Contract Systems, Inc.
- Distributor
- US Nationwide distribution in the states of MO, MN, MA, OH, NE.
- Lot
- UDI-DI: 00191072206244; Lot: 2405092; Exp: 05/09/2025
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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