Z-2009-2010

Microstream SCP H PLUS O2 ADU/INT 100UN Part Number: 010625

Name: Z-2009-2010 Microstream SCP H PLUS O2 ADU/INT 100UN Part Number: 010625
Creator: Oridion Medical 1987 Ltd.
Published: 2010-05-26
License: https://open.fda.gov/license/

Oridion Medical 1987 Ltd. / initiated 2010-05-26 / Terminated / root cause: manufacturing process

FDA source

Oridion Medical 1987 Ltd. began a recall of Microstream SCP H PLUS O2 ADU/INT 100UN Part Number: 010625 on 2010-05-26. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2009-2010
Status: Terminated
Initiated: 2010-05-26
Posted: 2010-07-13
Terminated: 2012-06-21
Recalling firm: Oridion Medical 1987 Ltd.
Product: Microstream SCP H PLUS O2 ADU/INT 100UN Part Number: 010625
Product code: cck
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.
Root cause tag: manufacturing process
FDA root cause: Process design
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.
Quantity in commerce: 13500 units (13 boxes/100 units)
Distribution: AZ, CA, FL, HI, LA, , MA, MO, NJ, OH, PA, WA, WI,
Product codes and lots: Lot numbers from Q0901006 to Q0908223. Produced between January and July 2009,

Product code cck

K011536Class IIMicrostream O2/co2 Oral Nasal FilterlineOridion Medical 1987 , Ltd. / cleared 2001-11-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)