Recall Z-0920-2014— Fresenius Medical Care Holdings, Inc.

Name: FDA recall Z-0920-2014
Creator: U.S. Food and Drug Administration
Published: 2013-12-17

Class II · Terminated

Class II FDA medical device recall by Fresenius Medical Care Holdings, Inc., initiated 2013-12-17, terminated 2021-05-18. FDA's recall record names no specific 510(k) clearance for this event. Product: 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: Bicarbonate Jug Adapter distributed prior to 510(k) approval.

Recalling firm: Fresenius Medical Care Holdings, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-12-17
Terminated: 2021-05-18
Firm location: Waltham, MA, United States

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.