Reported Jul 24, 2013 · Terminated
Edwards Lifesciences Suction Wand, models S099 and S0998B Suction wands are intended for hand held use and pericardial…
Edwards Lifesciences, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Edwards Lifesciences, LLC · 12050 Lone Peak Pkwy · Draper, UT · 84020-9414
Is this the product you have?
- 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.
- Lot codes and dates
- Models S099 and S099B
- Amount recalled
- S099: 171,587 units and S099B: 505,107 units
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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