American Contract Systems Biopsy Drape Pack convenience kit
FDA Recall #Z-2523-2024 — Class II — May 6, 2024
Product Description
American Contract Systems Biopsy Drape Pack convenience kit
Reason for Recall
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
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
224
Distribution
US Nationwide distribution in the states of CA, KS, ME, MN, MO, NE, and SD.
Code Information
UDI-DI 00191072202246; Lot 981241; Exp. Date 1/19/2025
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated