FDAFDA · Food and drugs·Recall number Z-1749-2013
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.
Published July 24, 2013 · Recall initiated: June 19, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Edwards Lifesciences, LLC
- Distributor
- Worldwide Distribution - USA (nationwide) and Canada.
- Lot
- Models S099 and S099B
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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