FDA Medical Device Recalls (openFDA)
Oridion Medical 1987 Ltd.: Microstream SCP H PLUS O2 ADU/INT 100UN Part Number: 010625
- Recall number
- Z-2009-2010
- Recalling firm
- Oridion Medical 1987 Ltd.
- Product
- Microstream SCP H PLUS O2 ADU/INT 100UN Part Number: 010625
- Status
- Terminated
- Initiated
- 2010-05-26
- Posted
- 2010-07-13
- Terminated
- 2012-06-21
- 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
- 13500 units (13 boxes/100 units)
- Distribution
- AZ, CA, FL, HI, LA, , MA, MO, NJ, OH, PA, WA, WI,
- Lot, serial or model codes
- Lot numbers from Q0901006 to Q0908223. Produced between January and July 2009,
- 510(k) numbers
- ["K011536"]
- PMA numbers
- not on file
- Product code
- cck
- Firm FEI
- 3001227743
- Firm city
- Jerusalem
- Firm state
- Har Hotzvim Industrial Park
- Firm country
- Israel
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28