Reported Oct 10, 2018 · Terminated
Retrograde Cardioplegia Cannula, Model Number RMG-0015S The Retrograde Cardioplegia Cannula is intended for use in…
Surge Medical Sales, LLC (DBA Surge Cardiovascular)
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: Surge Medical Sales, LLC (DBA Surge Cardiovascular) · 2680 Walker Ave Nw · Grand Rapids, MI · 49544-1385
Is this the product you have?
- Retrograde Cardioplegia Cannula, Model Number RMG-0015S The Retrograde Cardioplegia Cannula is intended for use in perfusing cardioplegia solutions retrograde through the coronary sinus by means of transatrial introduction.
- Lot codes and dates
- Lot code00794-030718
- Amount recalled
- 35 units
Where it was sold
Why it was recalled
The device was built with the rigid insertion stylet instead of the flexible stylet.
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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