FDA-Device2013-05-08Class II
Diacap(R) Ultra Dialysis Fluid Filter, Catalog Number 7107367. Intended to filter bacteria and endotoxins from dialysis fluid.
B. Braun Medical, Inc.
Hazard
There is the potential of the residual moisture of the Diacap Ultra membrane being reduced over time, which results in the reduction of the membrane permeability (ultrafiltration coefficient).
Sold states
Distribution and manufacturing dates for the expansion lots was reported as 5/23-6/14/2013 and 1/22-24/2013 respectively. Nationwide Distribution including the states of AZ, CA, DE, FL, GA, HI, IA, ID, IL, KS, KY, LA, MN, MO, NJ, NM, NY, OH, OR, PA, SC, SD, TN, TX, UT, WA and WV.
Affected count
1580
Manufactured in
901 Marcon Boulevard, Allentown, PA, United States
Products
Diacap(R) Ultra Dialysis Fluid Filter, Catalog Number 7107367. Intended to filter bacteria and endotoxins from dialysis fluid.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1183-2013Don't want to check this manually?
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