Oridion Medical and Philips Healthcare Microstream CO2 Filterline Recalled due to Potential Respiratory Compromise

The FDA informs Emergency Medicine and Pediatrics healthcare personnel that Oridion Medical and Philips Healthcare Microstream CO2 Filterline is recalled because plastic strands can be inhaled and may cause respiratory compromise leading to serious adverse events or death.

Background of Oridion Medical and Philips Healthcare Microstream CO2 Filterline

The Microstream CO2 Filterline is a medical device used for the measurement of exhaled carbon dioxide (CO2) during ventilation of newborn and infant patients. It is used by hospitals, emergency medical services and other health care providers.

FDA Alert on Oridion Medical and Philips Healthcare Microstream CO2 Filterline

FDA’s reason for the recall is that plastic strands located on the inner surface of the infant airway adapter may become dislodged and inhaled by the infant, leading to respiratory compromise and causing severe adverse events or death.

The affected models and lots of FilterLine H Set Infant/Neonate and VitaLine H Set Infant/Neonate are:

• Oridion Medical, Models: 006324, 010807. Lot numbers: M8330M10, M8386N10, M8411P10, M8451P10, M8477A11, M8514A11, M8572B11, M8406P10, M8544B11, M8286M10, M8300M10, M8406P10, M8544B11, M8555B11, M8575B11, M8286M10, M8300M10, M8544B11, M8535B11, M8573B11, M8409P10, M8476A11
• Philips Healthcare, Models: M1923A, 989803159581. Lot numbers: M8330M10, M8386N10, M8411P10, M8451P10, M8477A11, M8514A11, M8572B11, M8409P10.

The FDA classified this recall as Class I, meaning use of the products included in the recall may cause serious injuries or death.

Recommendation on Oridion Medical and Philips Healthcare Microstream CO2 Filterline

“Philips instructed users to immediately identify all products from affected lots, remove them from inventory and dispose in accordance with local regulations.”

Contacting the FDA to report cases with Oridion Medical and Philips Healthcare Microstream CO2 Filterline

In case of detection of adverse events or side effects related to the use of Oridion Medical and Philips Healthcare Microstream CO2 Filterline, healthcare professionals and patients should report it to the FDA’s MedWatch Safety Information and Adverse Event Reporting program through any of the following ways:

The report can be completed and submitted online at: www.fda.gov/MedWatch/report.htm

The form can be downloaded or requested by calling 1-800-332-1088, then completed and returned on the address indicated on the form

The completed form can be faxed to: 1-800-FDA-0178

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