Oridion Surestream CO2 Sampling Lines recallZ-1350-2012 · Oridion Medical 1987 Ltd. · initiated Dec 1, 2011
Terminated All recalls posted in March 2012
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Oridion Medical 1987 Ltd. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Surestream CO2 Sampling Lines-Connector may cause breakage of the microswitch inside the CO2 inlet
FDA root cause category: Device Design
What the company is doing
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]
Recall details
- Recall number
- Z-1350-2012
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Dec 1, 2011
- Posted by the FDA
- Mar 30, 2012
- Recalling firm
- Oridion Medical 1987 Ltd.
- Quantity
- 84 boxes (2100 untis)
- Product code
- CCK
- FDA submissions
- K980327
- Distribution
- USA Nationwide Distribution including the states of: AZ, CA, FL, HI, LA, MA, MO, NJ, NY, OH, OR, TX and WI.
Product description
Oridion Surestream CO2 Sampling Lines- Sure VentLine H Set Adult/Pediatric Part Number: 010987-03 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.
Code information (models, lots, serial numbers)
Lot Numbers: M8337N10, M8507A11, M8552B11
Other devices under the same FDA submission
6 devices cleared under K980327 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Microstream 006330Oridion Medical 1987 Ltd. · ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE1 recall0 reports
- Microstream 010808Oridion Medical 1987 Ltd. · ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE1 recall0 reports
- Microstream 015707_RMS1Oridion Medical 1987 Ltd. · ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE1 recall0 reports
- Microstream XS04624COV-05Oridion Medical 1987 Ltd. · ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE1 recall0 reports
- Microstream 006324COV-05Oridion Medical 1987 Ltd. · ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE1 recall0 reports
- Microstream 011108Oridion Medical 1987 Ltd. · Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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