Oridion Surestream CO2 Sampling Lines- SureLine Adult Part Number: 010976-03 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.
FDA Recall Z-1346-2012 · Posted 2012-03-30
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Recalling FirmOridion Medical 1987 Ltd.
Recall StatusTerminated
Product CodeCCK
Date Initiated2011-12-01
Date Terminated2012-06-04
Product Quantity19 units (475 boxes)
Reason for Recall
Surestream CO2 Sampling Lines-Connector may cause breakage of the microswitch inside the CO2 inlet
Firm 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]
Root Cause
Device Design
Distribution Pattern
USA Nationwide Distribution including the states of: AZ, CA, FL, HI, LA, MA, MO, NJ, NY, OH, OR, TX and WI.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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