Neuro Vascular, ANKV91A; Medical convenience kit
FDA Recall #Z-3236-2024 — Class II — August 7, 2024
Product Description
Neuro Vascular, ANKV91A; 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
1 unit
Distribution
US Nationwide distribution in the states of MO, MN, MA, OH, NE.
Code Information
UDI-DI: 00191072201232; Lot: 2405102; Exp: 05/10/2025
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated