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Terminated

Waste bottles Part Numbers/Article Numbers: 905-590/D512 and 905-802/D513. The waste bottles are used to collect waste from the ABL7XX and the ABL8XX blood gas analyzer after rinsing.

FDA Recall Z-1554-2009 · Posted 2009-07-15

Recalling FirmRadiometer America Inc
Recall StatusTerminated
Product CodeCHL
Date Initiated2009-04-16
Date Terminated2012-05-09
Product Quantity905-590 (D512): 35,552 bottles; 905-802 (D513): 45,204 bottles

Reason for Recall

When removing the waste bottle from the analyzer waste material may leak both from the analyzer and from the waste bottle.

Firm Action

Radiometer America Inc. issued a recall notification letter dated May 5, 2009 to all customers containing information on replacement of all potentially defective waste containers and instruction on how to handle any mounted waste containers. For further questions, contact Radiometer America Inc. at 1-800-736-0600.

Root Cause

Process design

Distribution Pattern

Worldwide Distribution to US and Canada.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K041874ABL800 FLEXRadiometer Medical Aps · 2004-10-08K002290ABL-700 SERIES, MODEL ABL 7XX (VARIOUS MODELS)Radiometer Medical A/S · 2000-09-13

Official Source

View FDA Recall →

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

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