FDA-Device2012-07-18Class II
Edwards Lifesciences Rigid Suction Wand, sterile. Model numbers S033 and SPC2081. Product Usage: These suction catheters are typically used to remove fluid on the external surface of the heart during cardiac surgery and therefore there is little risk of intravascular involvement.
Edwards Lifesciences, LLC
Hazard
Edwards is recalling Suction Wand models SPC2081 and S033 because the plastic tip attached to the metal suction wand may become detached during routine use.
Sold states
Worldwide Distribution - US (nationwide) including the states of CT, TX, CA, AZ, MO, and MD and the countries of Europe and Japan.
Affected count
1524 units
Manufactured in
12050 Lone Peak Pkwy, Draper, UT, United States
Products
Edwards Lifesciences Rigid Suction Wand, sterile. Model numbers S033 and SPC2081. Product Usage: These suction catheters are typically used to remove fluid on the external surface of the heart during cardiac surgery and therefore there is little risk of intravascular involvement.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1967-2012Don't want to check this manually?
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