Reported Jan 22, 2014 · Terminated

pO2 D999 membrane units. Distributed by Radiometer America, Inc., Westlake, OH 44145 pO2 membrane units, ordering…

Radiometer America Inc.

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: Radiometer America Inc · 810 Sharon Dr · Westlake, OH · 44145-1521

Is this the product you have?

  • pO2 D999 membrane units. Distributed by Radiometer America, Inc., Westlake, OH 44145 pO2 membrane units, ordering number 942-042 Intended use is in vitro testing of samples of whole blood for pO2 (partial pressure of oxygen).
Lot codes and dates
    • Part #: 942-042
    • Lot #: R0971
Amount recalled
209 boxes/6 membranes

Where it was sold

Why it was recalled

RADIOMETER became aware that the regarded lot pO2 units 942-042R0971 were produced with inner solution for pCO2 membrane units. This solution is a salt solution similar to the pO2 inner solution, but also contains glycerol which can be reduced at the cathode causing a suddenly rising zero current, causing the membrane unit to fail the following Cal2 calibration.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jun 19, 2014 · Data as of Sep 19, 6:05 PM UTC

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