Oridion CO2 sampling lines and water traps under the label: Surestream CO2 Sampling Lines: SureLine Adult Part No.010976

FDA device recall Z-1333-2012 · posted 2012-03-29 · Terminated

Recall details

Recalling firm

Oridion Medical 1987 Ltd.

Reason for recall

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

Action taken

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

Status

Terminated

Product code

CCK

Quantity affected

2 million

Distribution

Nationwide Distribution

Date initiated

2012-02-16

Date posted

2012-03-29

Date terminated

2013-09-13

Location

Jerusalem, Har Hotzvim Industrial Park, Israel

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