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Terminated

Capnostream20 Monitor with Masimo Pulse Oximetry Module - Part Number: CS 08659 - Oridion Medical

FDA Recall Z-0178-2008 · Posted 2007-11-28

Recalling FirmOridion Capnography Inc
Recall StatusTerminated
Product CodeDQA
Date Initiated2007-07-28
Date Terminated2008-09-08
Product Quantity6

Reason for Recall

Handle Cracking - Cracks in the handle will lead to disconnection of the handle from the monitor, causing the monitor to fall.

Firm Action

Oridion sent Dear Customer letters dated, August 21, 2007, informing users that a new monitor with the improved handle will be shipped by August 31, 2007.

Root Cause

Process design

Distribution Pattern

Nationwide Distribution- including states of AZ, CA, FL, MA, MO, OH, TX, WA, and WI,

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K060065CAPNOSTREAM20 TWO PARAMETER BEDSIDE MONITOR & CAPNOSTREAM10 ONE PARAMETER BEDSIDE MONITOROridion Capnography, Inc. · 2006-05-04

Official Source

View FDA Recall →

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

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