Reported Jul 25, 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
0006-006601 00-03110313-03221001-10271100-143414361440and 1441
- Amount recalled
- 648
This recall covers 15 products
The agency filed one notice per product. You are reading one of them; the other 14 are below.
2 more are in the archive.
Where it was sold
Why it was recalled
Terumo¿ Advanced Perfusion System 1 has displayed a Red X error message on multiple module icons indicating a loss or fluctuation of internal power on one side of the system's base. Terumo Cardiovascular Systems' initial investigation has determined that there may be more than one cause for the malfunction and is investigating further to determine the root cause. Potential risks with the loss or
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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