Z-1334-2012

Oridion CO2 sampling lines and water traps under the label: Omnistream CO2 Sampling Lines: OmniLine O2 Adult...

Name: Z-1334-2012 Oridion CO2 sampling lines and water traps under the label: Omnistream CO2 Sampling Lines: OmniLine O2 Adult...
Creator: Oridion Medical 1987 Ltd.
Published: 2012-02-16
License: https://open.fda.gov/license/

Oridion Medical 1987 Ltd. / initiated 2012-02-16 / Terminated / root cause: packaging

FDA source

Oridion Medical 1987 Ltd. began a recall of Oridion CO2 sampling lines and water traps under the label: Omnistream CO2 Sampling Lines: OmniLine O2 Adult Part No.007609; OmniLine O2 Pediatric Part No... on 2012-02-16. The reason FDA records is "CO2 sampling lines may have paper and plastic particulate present in the packaged units at levels that may exceed visual specification". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1334-2012
Status: Terminated
Initiated: 2012-02-16
Posted: 2012-03-29
Terminated: 2013-09-13
Recalling firm: Oridion Medical 1987 Ltd.
Product: Oridion CO2 sampling lines and water traps under the label: Omnistream CO2 Sampling Lines: OmniLine O2 Adult Part No.007609; OmniLine O2 Pediatric Part No 007610; Smart OmniLine Plus O2 Adult Part No.010177; Smart OmniLine Plus O2 Adult (package of 100 units) Part No.010213; Smart OmniLine O2 Pediatric Part No. 007606; ;Smart OmniBloc O2 Part No. 010946 Smart OmniLine Plus part No. 010172 Smart OmniLine Plus (package of 100 units) Part No 010212; Smart OmniLine Guardian O2 Part No. 012531; Smart OmniLine Guardian O2 Long Part No. 012532 OmniVentLine Set Part No. 012495
Product code: CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Reason for recall: CO2 sampling lines may have paper and plastic particulate present in the packaged units at levels that may exceed visual specification.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: Oridion notified Hospitals, Clinics, EMS with an "Important Communication" letter to clinicians dated February 12, 2012. The letter was intended to make US clinicians aware of an important issue relating to certain Oridion CO2 sampling lines, which may not fully meet quality requirements. In a few cases, paper and plastic particulate may be present in the packaged units at levels that exceed the visual specification. Recommended actions were included in the letter. Questions were directed to 1(781)-972-1252.
Quantity in commerce: 2 million
Distribution: Nationwide Distribution
Product codes and lots: All lots

Product code CCK

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)