Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

pO2 D999 membrane units. Distributed by Radiometer America Recalled by Radiometer America Inc Due to RADIOMETER became aware that the regarded lot pO2...

Date: June 10, 2013
Company: Radiometer America Inc
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Radiometer America Inc directly.

Affected Products

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).

Quantity: 209 boxes/6 membranes

Why Was This 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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Radiometer America Inc

Radiometer America Inc has 25 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report