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Terminated

Dri-Tek BG-OX Cartridge, Model #D7120, Cat. #946-003 Cartridges used in the NPT7 Analyzer, an in vitro diagnostic device.

FDA Recall Z-1261-06 · Posted 2006-07-27

Recalling FirmRadiometer America Inc
Recall StatusTerminated
Product CodeCHL
Date Initiated2006-05-01
Date Terminated2012-02-24
Product Quantity185

Reason for Recall

Air bubbles may be trapped on or close to the O2 sensor in the pO2 chamber of the cuvettes in cartridges used for blood gas analysis on NPT7 analyzer. This produces too high pO2 readings without a question mark.

Firm Action

The recalling firm initiated this recall with a letter to send to their customers, via Registered Mail, on 5/1/2006. The letter requests that the customers identify and discard the potentially defective cartridges from Lot #R0299. The letter is accompanied by a recall response page to be completed by the customer and faxed or mailed back to the Radiometer so that the customer can receive an equal number of replacement cartridges free-of-charge.

Root Cause

Other

Distribution Pattern

Nationwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K982928NPT7 SERIES PH/BLOOD GAS AND CO-OXIMETRY SYSTEMRadiometer America, Inc. · 1999-01-06

Official Source

View FDA Recall →

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

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