Reported Jul 18, 2012 · Terminated
Edwards Lifesciences Rigid Suction Wand, sterile. Model numbers S033 and SPC2081. Product Usage: These suction…
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 Rigid Suction Wand, sterile. Model numbers S033 and SPC2081
- Product UsageThese 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
- Lot codes and dates
- Lot numbers
5874981358802303588368475887740558909346590119105903536059085935591183915924153158705682587119645872223458771175588373375885524758904182589275185893603758936014589360275900963559030253590564705910321359124020591991725921872559235997
- Lot numbers
- Amount recalled
- 1524 units
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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