Radiometer America Inc: Medical Device Recall in 2014 - (Recall #: Z-0713-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

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).

Product Classification:

Class II

Date Initiated: June 10, 2013

Date Posted: January 22, 2014

Recall Number: Z-0713-2014

Event ID: 67044

Reason for Recall:

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.

Status: Terminated

Product Quantity: 209 boxes/6 membranes

Code Information:

Part #: 942-042, Lot #: R0971

Distribution Pattern:

Worldwide Distribution - US (nationwide) including states of: CO, CT, GA, MA, MO & MS and country of: Canada.

Voluntary or Mandated:

Voluntary: Firm initiated