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Gambro Renal Products, Incorporated recalls X-MARS Set (component of MARS Treatment Kit Type 1116/1 X-MARS US), Product Number 800541
Recalled August 20, 2014 · FDA recall Z-2207-2014 · Gambro Renal Products, Incorporated
Hazard
Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood. · FDA Class II
Units
401,451
Sold at
Worldwide Distribution.
Description
Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.
Product
X-MARS Set (component of MARS Treatment Kit Type 1116/1 X-MARS US), Product Number 800541
Manufacturer(s)
Gambro Renal Products, Incorporated
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →