Recall Z-2207-2014— Gambro Renal Products, Incorporated

Name: FDA recall Z-2207-2014
Creator: U.S. Food and Drug Administration
Published: 2014-07-18

Class II · Terminated

Class II FDA medical device recall by Gambro Renal Products, Incorporated, initiated 2014-07-18, terminated 2015-02-05. FDA's recall record names no specific 510(k) clearance for this event. Product: X-MARS Set (component of MARS Treatment Kit Type 1116/1 X-MARS US), Product Number 800541. Reason: Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood..

Recalling firm: Gambro Renal Products, Incorporated
Classification: Class II
Status: Terminated
Initiated: 2014-07-18
Terminated: 2015-02-05
Firm location: Lakewood, CO, United States

Product description

X-MARS Set (component of MARS Treatment Kit Type 1116/1 X-MARS US), Product Number 800541

Reason for recall

Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.

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