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Gambro Renal Products, Incorporated recalls Prisma TPE 2000 set. Product number 109672. Each set is packaged in a plastic pouch, 4 pouches per carton box
Recalled August 20, 2014 · FDA recall Z-2194-2014 · 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
Prisma TPE 2000 set. Product number 109672. Each set is packaged in a plastic pouch, 4 pouches per carton box
Manufacturer(s)
Gambro Renal Products, Incorporated
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →