Reported Sep 4, 2013 · Terminated
Medtronic Custom Perfusion System with Carmeda BioActive Surface. Model Numbers: CB1D82R12 and CB5N73R7. Sterilized by…
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 Carmeda BioActive Surface
- Model NumbersCB1D82R12 and CB5N73R7. Sterilized by Ethylene Oxide, Do no Reuse
- Product UsageUsage: This product is indicated for use in the extracorporeal circuit during cardiopulmonary surgery
- Lot codes and dates
- Lot
12096267121050991213966912166396121983221230995712416020206119223206120062206180336206233199206384131206496179206649807206699258206758209206851971206864385206919887207003072and 207071455
- Lot
- Amount recalled
- 217
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.
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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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