Z-1075-2014Class II

pCO2 D788 Membranes. Distributed by Radiometer America, Inc., Westlake, OH. An automatic or semi-automatic...

Name: Z-1075-2014 pCO2 D788 Membranes. Distributed by Radiometer America, Inc., Westlake, OH. An automatic or semi-automatic...
Creator: Radiometer America Inc
Published: 2013-07-05
License: https://open.fda.gov/license/

Radiometer America, Inc / initiated 2013-07-05 / Terminated

FDA source

Radiometer America Inc began a recall of pCO2 D788 Membranes. Distributed by Radiometer America, Inc., Westlake, OH. An automatic or semi-automatic instrument used to identify and quantify two or more... on 2013-07-05. FDA classified it as Class II and gives the reason as "RADIOMETER has become aware that some D788 pCO2 membranes can cause biased measurement results on patient results as well as QC results". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1075-2014
Classification: Class II
Status: Terminated
Initiated: 2013-07-05
Posted: 2014-02-24
Terminated: 2015-09-19
Recalling firm: Radiometer America, Inc
Product: 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 code: CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
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.
FDA root cause: Under Investigation by firm
Action: On 7/18/2013, the firm sent Product Notification letters to their customers.
Quantity in commerce: 38,890 units (7,860 units imported into the US)
Distribution: 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.
Product codes and lots: Model #: 942-063 Lot #'s: R338 to R493

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1075-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1075-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-05	2014-02-24

Product code CHL

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)