FDAFDA · Food and drugs·Recall number Z-1322-2013
Proplege Coronary Sinus Catheter model PR9, 11 French Introducer, kitted with PR9. Product Usage: The catheter introducer sheath kit provides access to the central venous circulation to facilitate catheter and guidewire insertion. The Proplege coronary sinus catheter provides retrograde cardioplegia during cardiopulmonary by-pass surgery.
Published May 22, 2013 · Recall initiated: January 25, 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 Lifesciences is recalling certain Proplege Coronary Sinus Catheter, model PR9 due to confirmed reports of blood leakage through the hemostasis valve in the introducer that is kitted with the catheter.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Edwards Lifesciences, LLC
- Distributor
- Worldwide Distribution - USA Nationwide including the states of: MD, NY, PA, CA, FL, AZ, AL, TX, VA, OH, MO, NC, GA, TN, CO, OR, SC, ME, IL, HI, NJ, WA, WI, CT, KY, LA and Canada.
- Lot
- Model PR9, lot numbers: 59385159, 59385164, 59385204, 59398000, 59398006, 59398008, 59400402, 59423199, 59423200, 59385159, 59385164, 59385204, 59398000, 59398006.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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