Z-1348-2012

Oridion Surestream CO2 Sampling Lines- SureLine O2 Part Number: 010979-03

Name: Z-1348-2012 Oridion Surestream CO2 Sampling Lines- SureLine O2 Part Number: 010979-03
Creator: Oridion Medical 1987 Ltd.
Published: 2011-12-01
License: https://open.fda.gov/license/

Oridion Medical 1987 Ltd. / initiated 2011-12-01 / Terminated / root cause: design

FDA source

Oridion Medical 1987 Ltd. began a recall of Oridion Surestream CO2 Sampling Lines- SureLine O2 Part Number: 010979-03 Product Usage: The intended use of SureStream sampling lines is to convey a sample of... on 2011-12-01. The reason FDA records is "Surestream CO2 Sampling Lines-Connector may cause breakage of the microswitch inside the CO2 inlet". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1348-2012
Status: Terminated
Initiated: 2011-12-01
Posted: 2012-03-30
Terminated: 2012-06-04
Recalling firm: Oridion Medical 1987 Ltd.
Product: Oridion Surestream CO2 Sampling Lines- SureLine O2 Part Number: 010979-03 Product Usage: The intended use of SureStream sampling lines is to convey a sample of a patients expired breath to a capnograph in order to measure CO2 partial pressure in intubated and non intubated patients.
Product code: CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Reason for recall: Surestream CO2 Sampling Lines-Connector may cause breakage of the microswitch inside the CO2 inlet
Root cause tag: design
FDA root cause: Device Design
Action: Oridion issued a Technical Note communication in March 2011 to field staff and end users globally. The Technical Note identified the affected product and provided instructions for user on the proper insertion of Surestream products. For questions contact your local distributor or Oridion at [email protected]
Quantity in commerce: 187 boxes (4675 units)
Distribution: USA Nationwide Distribution including the states of: AZ, CA, FL, HI, LA, MA, MO, NJ, NY, OH, OR, TX and WI.
Product codes and lots: Lot Numbers: M8204L10 M8357N10

Product code CCK

K012395Class IIMac-Line 02/Co2 Nasal Cannula Sample LineOridion Medical 1987 , Ltd. / cleared 2001-08-15

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)