Radiometer America Inc: Medical Device Recall in 2014 - (Recall #: Z-1075-2014)

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:

pCO2 D788 Membranes. Distributed by Radiometer America, Inc., Westlake, OH. An automatic or semi-automatic instrument used to identify and quantify two or more gases, and sometimes electrolytes, in whole blood using multiple special electrodes.

Product Classification:

Class II

Date Initiated: July 5, 2013

Date Posted: March 5, 2014

Recall Number: Z-1075-2014

Event ID: 67066

Reason for Recall:

RADIOMETER has become aware that some D788 pCO2 membranes can cause biased measurement results on patient results as well as QC results.

Status: Terminated

Product Quantity: 38,890 units (7,860 units imported into the US)

Code Information:

Model #: 942-063 Lot #'s: R338 to R493

Distribution Pattern:

Worldwide Distribution-USA (nationwide) including DC and the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV & WY, and the countries of Bermuda and Canada.

Voluntary or Mandated:

Voluntary: Firm initiated