Fresenius Bicarbonate Jug Adapter to the 2008 Series Hemodialysis machine Part Number: 650103. ...
FDA Recall #Z-0920-2014 — Class II — December 17, 2013
Product Description
Fresenius Bicarbonate Jug Adapter to the 2008 Series Hemodialysis machine Part Number: 650103. The adapter is a socket that accepts the 2008 machine spike to draw concentrate from the container.
Reason for Recall
Bicarbonate Jug Adapter distributed prior to 510(k) approval
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
703 units
Distribution
Nationwide Distribution.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated