FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-0038-2008
- 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.
- Status
- Terminated
- Initiated
- 2007-06-22
- Posted
- 2007-10-11
- Terminated
- 2012-04-25
- 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.
- Lot, serial or model codes
- Serial #905-671, 902-754
- 510(k) numbers
- ["K041874"]
- PMA numbers
- not on file
- Product code
- CHL
- Firm FEI
- 1523456
- Firm city
- Westlake
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28