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Terminated

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

FDA Recall Z-0038-2008 · Posted 2007-10-11

Recalling FirmRadiometer America Inc
Recall StatusTerminated
Product CodeCHL
Date Initiated2007-06-22
Date Terminated2012-04-25
Product Quantity289 pieces

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.

Firm 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.

Root Cause

Process design

Distribution Pattern

Product was distributed throughout the United States and Canada.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K041874ABL800 FLEXRadiometer Medical Aps · 2004-10-08

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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