Recall Z-0038-2008 ยท CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Radiometer America Inc
Pump waste tube for blood gas analysis kit. One yellowish/white rubber tube per plastic bag. Used on ABL800 Flex Series blood gas analyzers.
| Date | Oct 11, 2007 (initiated Jun 22, 2007) |
| Status | Terminated |
| Reason | 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 | 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 | 289 pieces |
| Distribution | Product was distributed throughout the United States and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041874 | ABL800 FLEX Radiometer Medical Aps, Oct 8, 2004 |