Microstream SMART CAPNOLINE PLUS ADU/INT 25UN Part Number: 009818 Oridion 3012176-011 Physio Control
FDA device recall Z-2003-2010 · posted 2010-07-13 · Terminated
Recall details
- Recalling firm
- Oridion Medical 1987 Ltd.
- 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.
- 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.
- Root cause
- Process design
- Status
- Terminated
- Product code
- cck
- Quantity affected
- 2961 boxes
- Distribution
- AZ, CA, FL, HI, LA, , MA, MO, NJ, OH, PA, WA, WI,
- Date initiated
- 2010-05-26
- Date posted
- 2010-07-13
- Date terminated
- 2012-06-21
- Location
- Jerusalem, Har Hotzvim Industrial Park, Israel
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MICROSTREAM ORAL NASAL CANNULA FILTERLINE (K011050) | Oridion Medical 1987 , Ltd. | 2001-05-04 |