Recall Z-1350-2012 ยท CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Oridion Medical 1987 Ltd.
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.
| Date | Mar 30, 2012 (initiated Dec 1, 2011) |
| Status | Terminated |
| Reason | Surestream CO2 Sampling Lines-Connector may cause breakage of the microswitch inside the CO2 inlet |
| 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 technicalsupport@oridion.com |
| Quantity | 84 boxes (2100 untis) |
| Distribution | USA Nationwide Distribution including the states of: AZ, CA, FL, HI, LA, MA, MO, NJ, NY, OH, OR, TX and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K980327 | MICROSTREAM FILTERLINE ICU Oridion Medical , Ltd., Apr 16, 1998 |