Reported Jul 18, 2012 · Terminated
System 1 Base 220/240V The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the…
Terumo Cardiovascular Systems Corporation
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: Terumo Cardiovascular Systems Corporation · 6200 Jackson Road · Ann Arbor, MI · 48103-9586
Is this the product you have?
- System 1 Base 220/240V The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.
- Lot codes and dates
- catalog number801764
- and serial numbers
0006-00660100-03110313-03221001-10271100-143414361440and1441
- Amount recalled
- 648 units
This recall covers 11 products
The agency filed one notice per product. You are reading one of them; the other 10 are below.
Where it was sold
- Nationwide
Why it was recalled
Terumo Cardiovascular Systems (Terumo CVS) has received reports of various roller pump occlusion malfunctions that could result in the inability to use the pump and would then require replacement with back-up equipment. Occlusion malfunctions include stiff/difficult to adjust occlusion, loss of occlusion setting, unequal roller-to-roller occlusion and inability to adjust the occlusion. If it is
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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