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Class I Medical Device Recall: Oridion Medical and Philips Healthcare Microstream CO2 Filterline (FilterLine H Set Infant/Neonat

Posted Jun 06 2011 12:00am

Recall Class: Class I

Date Recall Initiated: April 7, 2011

Product:
Microstream CO2 Filterline (FilterLine H Set Infant/Neonate, VitaLine H Set Infant/Neonate)

Affected models and lots:

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

The affected devices were manufactured and distributed between October 2010 and February 2011.

Use:

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

Recalling Firms:
Oridion Medical 1987 Ltd
7 Hamarpe St. P.O. box 45025
Jerusalem, Israel 91450

Philips Healthcare
3000 Minuteman Road
Andover, MA 01810

Reason for Recall:
Fine plastic strands on the inner surface of the infant/neonatal airway adapter may become dislodged and inhaled by the patient. Inhalation of the plastic strands on the defective devices may cause respiratory compromise, which could result in serious illness or death.

Public Contacts:

Oridion Medical:
Customers with questions related to this recall should contact Oridion at 1-888-674-3466 ext 1234., Monday – Friday, 8:30 a.m. to 5:30 p.m., Eastern Standard Time.

Philips Healthcare:
Customers with questions should contact David Rowe at (978) 659-3021.

FDA District: New England

FDA Comments:
Oridion Medical is notifying its distributors and customers via a field safety notice and is arranging for replacement of all recalled products.

Philips Healthcare notified all known users of the affected Philips-labeled devices in the U.S. and is in the process of notifying all customers world-wide.  In its recall communication, Philips instructed users to immediately identify all products from affected lots, remove them from inventory and dispose in accordance with local regulations. 

To date, Oridion Medical and Philips Healthcare have not received any reports of injuries related to this issue.

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.

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