Z-0038-2008

Pump waste tube for blood gas analysis kit. One yellowish/white rubber tube per plastic bag. Used on ABL800...

Name: Z-0038-2008 Pump waste tube for blood gas analysis kit. One yellowish/white rubber tube per plastic bag. Used on ABL800...
Creator: Radiometer America Inc
Published: 2007-06-22
License: https://open.fda.gov/license/

Radiometer America, Inc / initiated 2007-06-22 / Terminated / root cause: manufacturing process

FDA source

Radiometer America Inc began a recall of Pump waste tube for blood gas analysis kit. One yellowish/white rubber tube per plastic bag. Used on ABL800 Flex Series blood gas analyzers on 2007-06-22. The reason FDA records is "Tube may break. The firm discovered that the yellowish/white tubes used in their blood gas analyzers (ABL800 Flex Series) were manufactured incorrectly. These tubes have the potential to break off at the black plastic...". 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-0038-2008
Status: Terminated
Initiated: 2007-06-22
Posted: 2007-10-11
Terminated: 2012-04-25
Recalling firm: Radiometer America, Inc
Product: Pump waste tube for blood gas analysis kit. One yellowish/white rubber tube per plastic bag. Used on ABL800 Flex Series blood gas analyzers.
Product code: CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Reason for recall: Tube may break. The firm discovered that the yellowish/white tubes used in their blood gas analyzers (ABL800 Flex Series) were manufactured incorrectly. These tubes have the potential to break off at the black plastic connectors. The breakage may occur during the installation of the tubes or after a short time in use.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: By telephone call or service representative visit beginning July 18, 2007, Consumers/End Users are asked to locate the analyzers and yearly service kits concerned and replace all pump tubes with new ones.
Quantity in commerce: 289 pieces
Distribution: Product was distributed throughout the United States and Canada.
Product codes and lots: Serial #905-671, 902-754

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)