Reported Aug 29, 2012 · Terminated
Interface module for CDl System 500 Product Usage: The Interface Module for CDl 500 is the interface between the CDl…
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?
- Interface
- module for CDl System 500 Product UsageThe Interface Module for CDl 500 is the interface between the CDl 500 monitor and the system. The
- module performs the following functionsCommunicates primary pump flow data to the CDl 500 Receives blood parameter data from the CDl 500
- Lot codes and dates
- catalog number803479
- and serial numbers
00009-0012200124-0021000213-0036500367-00458and 00461-00596
- Amount recalled
- 582 units
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was recalled
Terumo Cardiovascular Systems has received reports of malfunctions involving the loss of data transfer capabilities using the data transfer capabilities using modules on the Terumo Advanced Perfusion System 1. Some reports stated that the odor of smoke was as associated with the failures. The malfunctions occurred during set-up, during cardiopulmonary bypass, and during routine testing of the modu
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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