Reported Feb 20, 2013 · Terminated
Terumo CDI 101 Hematocrit/Oxygen Saturation Monitoring System. Monitors blood/oxygen saturation, hematocrit and…
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?
- Terumo CDI 101 Hematocrit/Oxygen Saturation Monitoring System. Monitors blood/oxygen saturation, hematocrit and hemoglobin levels.
- Lot codes and dates
- Catalog number101
- and Serial Numbers
85 of 85 codes
0503100010171070107110731074107610771080108210831107-11101115-111711241126-1134113611371139-11461148-11521154-11561159-11621164-11661168-117711821185-11901192119311951197119812251228122912371239-12411243-124512471249-13261332-13391344-134713491350-13631365-14091411-143614381440-14471449-14531455-14631465-14821484-14921494-15521555-15651567-160016021605-16071609-16111613-16231625-16291632-1651
- Amount recalled
- 622 units
Why it was recalled
Inaccurate readings. Software contains unused (turned off) accuracy correction factors for slope (gain) and offset (bias) for Hematocrit/Saturation calculations. The accuracy on any cuvette size did not meet the specifications.
This product could cause temporary or reversible health problems — stop using it.
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