Recall Z-2012-2010 ยท CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Oridion Medical 1987 Ltd.
Microstream FILTERLINE SET ADU/PED 25UN Part Number: XS04620-01 Oridion XS04661 Physio Control
| Date | Jul 13, 2010 (initiated May 26, 2010) |
| Status | Terminated |
| Reason | The Microstream Filterline may not be recognized by the monitor when connected. No CO2 readings will be displayed and no alarms may sound for unmonitored patients. Replacing the filterline may delay treatment. |
| Root cause | Process design |
| Action | Oridion notified customers by letter on 5/26/10 and requested that they remove the FilterLines from the related production lots from the field and an immediate replacement with FilterLines from subsequent production lots. Questions are directed to the responsible person at the supplier named in the letter, or to Oridion Capnography at 888-674-3466. |
| Quantity | 142,875 units (5715 boxes/25 ) |
| Distribution | AZ, CA, FL, HI, LA, , MA, MO, NJ, OH, PA, WA, WI, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K980324 | MICROSTREAM FILLERLINE OR/EMS Oridion Medical , Ltd., Apr 16, 1998 |