Reported Sep 4, 2013 · Terminated
Medtronic Custom Perfusion System with Trillium BioSurface (a polymer containing non-leaching heparin). Model Numbers:…
Medtronic Inc. Cardiac Rhythm Disease Management
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: Medtronic Inc. Cardiac Rhythm Disease Management · 8200 Coral Sea St NE · Saint Paul, MN · 55112-4391
Is this the product you have?
- Medtronic Custom Perfusion System with Trillium BioSurface (a polymer containing non-leaching heparin)
- Model Numbers
TL4X17R8TL5D01RTL5D02RTL5D02R3TL5D02R5and TL6A65R7. Sterilized by Ethylene OxideDo no Reuse
- Product UsageUsage: This product is indicated for use in the extracorporeal circuit during cardiopulmonary surgery
- Lot codes and dates
- Lot
1164695511669565116723121171319511724203117499651175003611787651117999821182229911822308118787271189254911908754119776721198237811990416120198951203369112075354120897901209622812105079121111651213969612155284121725961217811812182890121916581220495112204958122217931222754412233759122364651229217112323842123854311239936312403798206110970206141990206142625206388507206476850206618547206649829206720637206758173206758215206851679206919848207003064and 207030516
- Lot
- Amount recalled
- 758
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
Medtronic was notified that Edwards Lifesciences has initiated a product recall for the Rigid Suction Wand, model S099B. The Wands are included within certain Perfusion Tubing Packs that are manufactured and distributed by Medtronic.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
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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