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Terminated

Model #842-326 (pump tube for waste) & Model #842-327 (pump tube for solution), Waste Tubing used on ABL 7xx and ABL8xx, component of the ABL700/800 Blood Gas Analyzers, also included in service kits part no. 905-671

FDA Recall Z-1260-06 · Posted 2006-07-26

Recalling FirmRadiometer America Inc
Recall StatusTerminated
Product CodeCHL
Date Initiated2006-05-22
Date Terminated2012-04-17
Product Quantity2500 Units in U.S. & 76 Units in Canada

Reason for Recall

An increased failure rate was observed with the yellow rubber tubing. The tubing was found to be leaking blood and solutions after distribution.

Firm Action

The recalling firm issued a letter to their customers dated 5/22/2006. The letter informs the customer(s) of the tubing defect and provides the customer with one (1) tubing to deal with any immediate needs which they may have. Should the customer require additional waste pump tubing replacements, the letter is accompanied by a FAX FORM which can be used to request any amount of additional replacement tubing required. The letter also shows tthe address to which the replacement tubing is to be delivered, and provides a Purchase Order request to be used, if required.

Root Cause

Other

Distribution Pattern

Nationwide to user/customers in the U.S. and in Canada

Official Source

View FDA Recall →

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

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