FDA Recall
Terminated
Microstream SMART CAPNOLINE PLUS O2 ADU/INT 25UN Part Number: 009822 Oridion 3012176-012 Physio Control
Recall: Z-2004-2010
·
Initiated May 26, 2010
Recall
- Recall Number
- Z-2004-2010
- Event Number
- 55790
- Firm
- Oridion Medical
- FEI Number
- 3001227743
- Product Code
- cck
- Status
- Terminated
- Root Cause
- Process design
- Initiated
- May 26, 2010
- Posted
- July 13, 2010
- Terminated
- June 21, 2012
- Address
- 1987 Ltd. 7 Hamarpe St. P.O. Box 45025, Har Hotzvim Industrial Park Jerusalem Israel
Description
Microstream SMART CAPNOLINE PLUS O2 ADU/INT 25UN Part Number: 009822 Oridion 3012176-012 Physio Control
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.
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.
Distribution
AZ, CA, FL, HI, LA, , MA, MO, NJ, OH, PA, WA, WI,
Quantity
5426 boxes