FDA-Device2013-07-24Class II
Edwards Lifesciences Suction Wand, models S099 and S0998B Suction wands are intended for hand held use and pericardial sumps are intended for stationary use in removing excess fluid from the surgical field.
Edwards Lifesciences, LLC
Hazard
Edwards is recalling certain lots of Rigid Suction Wands because they discovered plastic particulate inside the sterile pouch and within the internal diam ether of the wand.
Sold states
Worldwide Distribution - USA (nationwide) and Canada.
Affected count
S099: 171,587 units and S099B: 505,107 units
Manufactured in
12050 Lone Peak Pkwy, N/A, Draper, UT, United States
Products
Edwards Lifesciences Suction Wand, models S099 and S0998B Suction wands are intended for hand held use and pericardial sumps are intended for stationary use in removing excess fluid from the surgical field.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1749-2013Don't want to check this manually?
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