ASSY, POWER SUPPLY 130V 50HZ. This component is used with the following machines: 2008T Hemodial...
FDA Recall #Z-1015-2015 — Class II — December 16, 2014
Product Description
ASSY, POWER SUPPLY 130V 50HZ. This component is used with the following machines: 2008T Hemodialysis Machine, 2008K Hemodialysis Delivery Equipment, 2008 K2 Hemodialysis Delivery Equipment 2008K@home Hemodialysis Delivery System
Reason for Recall
Unqualified power assemblies shipped to customers.
Recalling Firm
Fresenius Medical Care Holdings, Inc. — Waltham, MA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
10
Distribution
Distributed in OK and FL.
Code Information
4P¿226813; 4P¿226815; 4P-226817; 4P-226818; 4P¿226819; 4P-226820; 4P-226821; 4P-226822
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated