June 8, 2011 – A nationwide Class 1 Medical Device Recall has been issued for several models of Microstream CO2 Filterline devices after new information has linked the products to a high probability of injury or death in infants and newborns. A fundamental defect in the devices may allow plastic strands to be inhaled by babies, causing potentially life-threatening respiratory problems.
Free Microstream CO2 Filterline Recall Case Evaluation: If your child or other loved one has been injured by a Microstream CO2 Filterline medical device, you should contact our law firm immediately. You may be entitled to compensation by filing a lawsuit and we can help.
What’s the problem?
According to new information received by the U.S. Food & Drug Administration (FDA), Microstream CO2 Filterline products – which are used to measure carbon dioxide levels exhaled by infants during ventilation – contain fine plastic strands on the inner surface of the infant airway adapter that may become dislodged and inhaled by babies. This defect may cause catastrophic respiratory problems, potentially leading to serious injury or death.
The initial Microstream CO2 Filterline recall was first announced in April, but on June 6 the FDA upgraded the status to a Class 1 Medical Device Recall. 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. This urgent nationwide recall includes:
- Microstream Co2 Filterlines (FilterLine H Set Infant/Neonate, VitaLine H Set Infant/Neonate) by Oridion Medical with model numbers 006324 and 010807
- Microstream Co2 Filterlines by Philips Healthcare with model numbers M1923A and 989803159581
These devices were manufactured and distributed between October 2010 and February 2011. Both Oridion and Phillips Healthcare are currently in the process of notifying customers worldwide. A complete list of lot numbers affected by this recall is available in the FDA Class 1 medical device recall notification. Users are advised to immediately identify all products from affected lots, remove them from inventory and dispose in accordance with local regulations.
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The Product Liability Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Microstream CO2 Filterline recall lawsuits. We are handling individual litigation nationwide and currently accepting new injury cases in all 50 states.