Pump waste tube for blood gas analysis kit. One yellowish/white rubber tube per plastic bag. Used on ABL800 Flex Series
FDA device recall Z-0038-2008 · posted 2007-10-11 · Terminated
Recall details
- Recalling firm
- Radiometer America Inc
- 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.
- Action taken
- 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.
- Root cause
- Process design
- Status
- Terminated
- Product code
- CHL
- Quantity affected
- 289 pieces
- Distribution
- Product was distributed throughout the United States and Canada.
- Date initiated
- 2007-06-22
- Date posted
- 2007-10-11
- Date terminated
- 2012-04-25
- Location
- Westlake, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ABL800 FLEX (K041874) | Radiometer Medical Aps | 2004-10-08 |