Pump waste tube for blood gas analysis kit. One yellowish/white rubber tube per plastic bag. Used on ABL800 Flex Series blood gas analyzers.
This recall has been terminated (originally issued October 11, 2007).
- Company
- Radiometer America Inc
- Recall Initiated
- June 22, 2007
- Posted
- October 11, 2007
- Terminated
- April 25, 2012
- Recall Number
- Z-0038-2008
- Quantity
- 289 pieces
- Firm Location
- Westlake, OH
- Official Source
- View on FDA website ↗
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.
Distribution
Product was distributed throughout the United States and Canada.
Lot / Code Info
Serial #905-671, 902-754
Root Cause
Process design
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.
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