FDAFDA · Food and drugs·Recall number Z-1985-2013
Edwards Lifesciences Suction Wand Model S099B, packaged in Sorin Group Heart/Lung Perfusion Packs.
Published August 28, 2013 · Recall initiated: July 8, 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
Sorin Group is recalling certain lots of Edwards Lifesciences Suction Wand Model S099B due to presence of plastic particles inside the pouch.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Sorin Group USA, Inc.
- Distributor
- Nationwide Distribution
- Lot
- Model S099B
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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