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Terminated

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

FDA Recall Z-1334-2012 · Posted 2012-03-29

Recalling FirmOridion Medical 1987 Ltd.
Recall StatusTerminated
Product CodeCCK
Date Initiated2012-02-16
Date Terminated2013-09-13
Product Quantity2 million

Reason for Recall

CO2 sampling lines may have paper and plastic particulate present in the packaged units at levels that may exceed visual specification.

Firm 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.

Root Cause

Packaging process control

Distribution Pattern

Nationwide Distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K093388SMART CAPNOLINE GUARDIANOridion Medical 1987 , Ltd. · 2010-03-04K042665SMART BITEBLOCOridion Medical 1987 , Ltd. · 2004-11-23K013845MODIFICATION TO: MAC-LINE O2/CO2 ORAL NASAL CANNULA SAMPLE LINEOridion Medical 1987 , Ltd. · 2001-11-29K012395MAC-LINE 02/CO2 NASAL CANNULA SAMPLE LINEOridion Medical 1987 , Ltd. · 2001-08-15K980324MICROSTREAM FILLERLINE OR/EMSOridion Medical , Ltd. · 1998-04-16

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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