ENT, COEN27N; Medical convenience kit
FDA Recall #Z-3241-2024 — Class II — August 7, 2024
Product Description
ENT, COEN27N; Medical convenience kit
Reason for Recall
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.
Recalling Firm
American Contract Systems, Inc. — Kansas City, MO
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
66 units
Distribution
US Nationwide distribution in the states of MO, MN, MA, OH, NE.
Code Information
UDI-DI: 00191072206244; Lot: 2405092; Exp: 05/09/2025
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated