Microstream FILTERLINE H SET ADULT/PEDIATRIC 100 UN recallZ-2011-2010 · Oridion Medical 1987 Ltd. · initiated May 26, 2010
Terminated All recalls posted in July 2010
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Oridion Medical 1987 Ltd. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Process design
What the company is doing
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.
Recall details
- Recall number
- Z-2011-2010
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- May 26, 2010
- Posted by the FDA
- Jul 13, 2010
- Recalling firm
- Oridion Medical 1987 Ltd.
- Quantity
- 1200 units (12 boxes/100 units)
- Product code
- cck
- FDA submissions
- K980327
- Distribution
- AZ, CA, FL, HI, LA, , MA, MO, NJ, OH, PA, WA, WI,
Product description
Microstream FILTERLINE H SET ADULT/PEDIATRIC 100 UN Part Number: 010580-01
Code information (models, lots, serial numbers)
Lot numbers from Q0901006 to Q0908223. Produced between January and July 2009,
Other devices under the same FDA submission
6 devices cleared under K980327 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Microstream 006330Oridion Medical 1987 Ltd. · ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE1 recall0 reports
- Microstream 010808Oridion Medical 1987 Ltd. · ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE1 recall0 reports
- Microstream 015707_RMS1Oridion Medical 1987 Ltd. · ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE1 recall0 reports
- Microstream XS04624COV-05Oridion Medical 1987 Ltd. · ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE1 recall0 reports
- Microstream 006324COV-05Oridion Medical 1987 Ltd. · ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE1 recall0 reports
- Microstream 011108Oridion Medical 1987 Ltd. · Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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