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Terminated

Microstream NIVLINE ADULT 25UN Part Number: 008174

FDA Recall Z-2000-2010 · Posted 2010-07-13

Recalling FirmOridion Medical 1987 Ltd.
Recall StatusTerminated
Product CodeCCK
Date Initiated2010-05-26
Date Terminated2012-06-21
Product Quantity4275 units (171 boxes/25 units)

Reason for Recall

The Microstream Filterline may not be recognized by the monitor when connected. No CO2 readings will be displayed and no alarms may sound for unmonitored patients. Replacing the filterline may delay treatment.

Firm Action

Oridion notified customers by letter on 5/26/10 and requested that they remove the FilterLines from the related production lots from the field and an immediate replacement with FilterLines from subsequent production lots. Questions are directed to the responsible person at the supplier named in the letter, or to Oridion Capnography at 888-674-3466.

Root Cause

Process design

Distribution Pattern

AZ, CA, FL, HI, LA, , MA, MO, NJ, OH, PA, WA, WI,

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K980325MICROSTREAM NASAL CANNULA FILTERLINEOridion Medical , Ltd. · 1998-04-16

Official Source

View FDA Recall →

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

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