Z-1319-06

D711, Reference Membranes, Part #942-058, used with the ABL835 Blood Gas Analyzers

Name: Z-1319-06 D711, Reference Membranes, Part #942-058, used with the ABL835 Blood Gas Analyzers
Creator: Radiometer America Inc
Published: 2005-06-17
License: https://open.fda.gov/license/

Radiometer America, Inc / initiated 2005-06-17 / Terminated

FDA source

Radiometer America Inc began a recall of D711, Reference Membranes, Part #942-058, used with the ABL835 Blood Gas Analyzers on 2005-06-17. The reason FDA records is "The recalled membranes cause the status value of the pH and electrolyte electrodes to be offset causing readings outside of the acceptable range". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1319-06
Status: Terminated
Initiated: 2005-06-17
Posted: 2006-08-02
Terminated: 2011-09-14
Recalling firm: Radiometer America, Inc
Product: D711, Reference Membranes, Part #942-058, used with the ABL835 Blood Gas Analyzers.
Product code: CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Reason for recall: The recalled membranes cause the status value of the pH and electrolyte electrodes to be offset causing readings outside of the acceptable range.
FDA root cause: Other
Action: The recalling firm notified their distributor/customers of this recall, via telephone on 6/17/2005, at which time, the customers were asked to destroy any and all suspect reference membranes found on-site and at their subaccount customer locations.
Quantity in commerce: 13 boxes/4 membranes per box
Distribution: Nationwide, including TX, OK, MI, CO, NY, and Canada.
Product codes and lots: Lot Code: R0308, Expiration Date: 4/07; Lot Code: R0309, Expiration Date: 5/07; and Lot Code: R0310, Expiration Date: 5/07.

Product code CHL

K041874Class IIAbl800 FlexRadiometer Medical Aps / cleared 2004-10-08

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)