Microstream SMART CAPNOLINE PLUS O2 100UN Part Number: 010210 Oridion 3012176-112 Physio Control
This recall has been terminated (originally issued July 13, 2010).
- Company
- Oridion Medical
- Recall Initiated
- May 26, 2010
- Posted
- July 13, 2010
- Terminated
- June 21, 2012
- Recall Number
- Z-2007-2010
- Quantity
- 1119 boxes
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
AZ, CA, FL, HI, LA, , MA, MO, NJ, OH, PA, WA, WI,
Lot / Code Info
Lot numbers from Q0901006 to Q0908223. Produced between January and July 2009,
Root Cause
Process design
Action Taken
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.