Z-0713-2014Class II

pO2 D999 membrane units. Distributed by Radiometer America, Inc., Westlake, OH 44145 pO2 membrane units...

Name: Z-0713-2014 pO2 D999 membrane units. Distributed by Radiometer America, Inc., Westlake, OH 44145 pO2 membrane units...
Creator: Radiometer America Inc
Published: 2013-06-10
License: https://open.fda.gov/license/

Radiometer America, Inc / initiated 2013-06-10 / Terminated / root cause: manufacturing process

FDA source

Radiometer America Inc began a recall of pO2 D999 membrane units. Distributed by Radiometer America, Inc., Westlake, OH 44145 pO2 membrane units, ordering number 942-042 Intended use is in vitro... on 2013-06-10. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0713-2014
Classification: Class II
Status: Terminated
Initiated: 2013-06-10
Posted: 2014-01-10
Terminated: 2014-06-19
Recalling firm: Radiometer America, Inc
Product: 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 code: CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
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.
Root cause tag: manufacturing process
FDA root cause: Mixed-up of materials/components
Action: Radiometer sent a Product Notification letter dated June 18, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check their inventory and remove any affected product, discard all affected product in their possession, and complete page 2 of the letter and return to their Radiometer representative. Radiometer will replace any quantity of affected product they have at their location. Customers with questions were instructed to contact Radiometer America Technicial Support at 1-800-736-0600, opt 4. For questions regarding this recall call 440-871-8900, ext 209.
Quantity in commerce: 209 boxes/6 membranes
Distribution: Worldwide Distribution - US (nationwide) including states of: CO, CT, GA, MA, MO & MS and country of: Canada.
Product codes and lots: Part #: 942-042, Lot #: R0971

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0713-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0713-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-22	2014-01-10

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)