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Gambro Renal Products, Incorporated recalls Prisma HF1000 preset (new design). Product number 107639. Each set is packaged in a plastic pouch, 4 pouches per carton
Recalled August 20, 2014 · FDA recall Z-2200-2014 · 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 HF1000 preset (new design). Product number 107639. 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 →