Reported Aug 21, 2013 · Terminated
Terumo¿ Advanced Perfusion System 1: 220/240V AC, Advanced Perfusion System 1 The Terumo¿ Advanced Perfusion System 1…
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 Rd · Ann Arbor, MI · 48103-9586
Is this the product you have?
- Terumo¿
- Advanced Perfusion System 1220/240V AC, Advanced Perfusion System 1 The Terumo¿ Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used by a qualified perfusionist who is experienced in the operation of Sarns " or similar equipment
- Lot codes and dates
- Catalog number801764
- Amount recalled
- 1657
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
- Nationwide
Why it was recalled
The operators manual does not fully describe the sequence of expected events that will occur when a specific operating condition exists. Specifically, if the user is adjusting the System 1 centrifugal pump speed via the Central Control Monitor at the same time an alarm condition occurs with configuration for a pump coast response, the labeling in the operators manual does not fully describe how the pump will react.
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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