Reported May 22, 2013 · Terminated
Proplege Coronary Sinus Catheter model PR9, 11 French Introducer, kitted with PR9. Product Usage: The catheter…
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?
Proplege Coronary Sinus Catheter model PR911 French Introducerkitted with PR9
- Product UsageThe 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
- Lot codes and dates
- Model PR9
- lot numbers
5938515959385164593852045939800059398006593980085940040259423199594232005938515959385164593852045939800059398006
- Amount recalled
- 807
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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