FDA-Device2014-08-20Class II
Prisma HF1000 preset (new design). Product number 107639. Each set is packaged in a plastic pouch, 4 pouches per carton box
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.
Sold states
Worldwide Distribution.
Affected count
401,451
Manufactured in
14143 Denver West Pkwy, N/A, Lakewood, CO, United States
Products
Prisma HF1000 preset (new design). Product number 107639. Each set is packaged in a plastic pouch, 4 pouches per carton box
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2200-2014Don't want to check this manually?
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