Oridion Surestream CO2 Sampling Lines- Sure VentLine Set Adult/Pediatric Part Number: 010986-03 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.
This recall has been terminated (originally issued March 30, 2012).
- Company
- Oridion Medical
- Recall Initiated
- December 1, 2011
- Posted
- March 30, 2012
- Terminated
- June 4, 2012
- Recall Number
- Z-1349-2012
- Quantity
- 481 boxes (12025 untis)
- Official Source
- View on FDA website ↗
Reason for Recall
Surestream CO2 Sampling Lines-Connector may cause breakage of the microswitch inside the CO2 inlet
Distribution
USA Nationwide Distribution including the states of: AZ, CA, FL, HI, LA, MA, MO, NJ, NY, OH, OR, TX and WI.
Lot / Code Info
Lot numbers: M8210L10, M8269M10, M8446P10, M8463A11
Root Cause
Device Design
Action Taken
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 technicalsupport@oridion.com
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