Custom Healthcare Systems, Inc. Inpatient Dialysis Kit PAK-19244. Single use. Dialysis kit
FDA Recall #Z-0863-2020 — Class II — December 20, 2019
Product Description
Custom Healthcare Systems, Inc. Inpatient Dialysis Kit PAK-19244. Single use. Dialysis kit
Reason for Recall
A component (1961 TELFA PAD 2 X 3) contains LATEX and was used in the Medical Convenience Kit(PAK-19244). Case label and device label for product did NOT show that the Medical Convenience Kit contained LATEX.
Recalling Firm
Custom Healthcare Systems, Inc. — Richmond, VA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
240 kits
Distribution
US Distribution to IL.
Code Information
LOT NUMBER: 20190614, expires February 1, 2020 UNIQUE DEVICE IDENTIFIER: (01)00811870033261(17)200201(10)20190614
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated