Reported Jul 24, 2013 · Terminated
CDI Blood Parameter Monitoring System 500 with Arterial blood parameter modules and Hematocrit/Saturation probe.…
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?
- CDI Blood Parameter Monitoring System 500 with Arterial blood parameter modules and Hematocrit/Saturation probe. Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH, PCO2, PO2, K+, oxygen saturation, hematocrit, hemoglobin, and temperature are desired.
- Lot codes and dates
- Catalog number500AHCT*
- and serial numbers
323 of 323 codes
10231025-10271029-10311034103510371040104510481054-10581060-1062106410651072-10741076-10951098-11001106-111011141116-1129113111321141-11451153-11651169-11801186-11911194-12101212-1215122112301237-12431249-12531256-12601265-12691275-12841290-12941300-1303131013111316-13201322-13311335-13391345-1349135913781384-13881394-13981409-141314191434-14381444-14481454-14581469-1478148114821484-14931495-15031505-152015281531-15531555-1558
- Amount recalled
- 3972 unit since 4/26/12
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
Why it was recalled
Terumo discovered through its own testing that CDI 500 Blood Parameter Monitoring System software contains inaccuracies associated with a software algorithm, and a software update has been developed to address this issue and a premarket notification (K130425) has been submitted to the agency. Once clearance is received for this premarket notification from the US FDA, Terumo CVS will implement the
This product could cause temporary or reversible health problems — stop using it.
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