FDA Medical Device Recalls (openFDA)
Oridion Medical 1987 Ltd.: Oridion Surestream CO2 Sampling Lines- Smart SureLine Plus O2 adult Part Number: 010981-03 Product Usage: The intended use of SureStream sampling lines is to convey a sample of a patients expired breath to a capnograph in order to measure CO2 partial pressure in intubated and non intubated patients.
- Recall number
- Z-1347-2012
- Recalling firm
- Oridion Medical 1987 Ltd.
- Product
- Oridion Surestream CO2 Sampling Lines- Smart SureLine Plus O2 adult Part Number: 010981-03 Product Usage: The intended use of SureStream sampling lines is to convey a sample of a patients expired breath to a capnograph in order to measure CO2 partial pressure in intubated and non intubated patients.
- Status
- Terminated
- Initiated
- 2011-12-01
- Posted
- 2012-03-30
- Terminated
- 2012-06-04
- Reason
- Surestream CO2 Sampling Lines-Connector may cause breakage of the microswitch inside the CO2 inlet
- Root cause
- Device Design
- Action
- Oridion issued a Technical Note communication in March 2011 to field staff and end users globally. The Technical Note identified the affected product and provided instructions for user on the proper insertion of Surestream products. For questions contact your local distributor or Oridion at technicalsupport@oridion.com
- Quantity
- 70 boxes (1750 unts)
- Distribution
- USA Nationwide Distribution including the states of: AZ, CA, FL, HI, LA, MA, MO, NJ, NY, OH, OR, TX and WI.
- Lot, serial or model codes
- Lot Numbers: M8209L10, M8262M10
- 510(k) numbers
- ["K012391"]
- 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