FDA Alert: Draeger Initiates Voluntary Recall of Carina Sub-Acute Care Ventilators Over Airpath Contaminants
Draeger Carina Sub Acute Care Ventilator Lawsuit Lawyers
Draeger Medical, Inc. has proactively initiated a recall of its Carina Sub-Acute Care Ventilators due to contamination concerns. The company discovered that when used for more than 30 days by pediatric patients, the airpath in these devices contains unacceptable levels of contaminants. In particular, tests have detected the presence of polyether polyurethane (PE-PUR), leading to emissions of 1,3-Dichloropropan-2-ol, a substance with potential carcinogenic effects.
Nature of the Recall
It’s essential to clarify that this is a voluntary corrective action by Draeger, not a directive to remove the product from the market entirely.
Guidelines for Clinicians
Healthcare professionals are advised to continue using these ventilators for adult patient care but are explicitly warned against their use for pediatric patients.
FDA Classification
The U.S. Food and Drug Administration (FDA) has categorized this as a Class I recall, which is its most severe classification. The implication is that continued use of these devices, especially for pediatric patients, could result in significant injuries or even fatalities.
By being vigilant and adhering to these guidelines, clinicians can mitigate the risks associated with these ventilators while the company works on resolving the issue.
Filing a Civil Lawsuit Regarding Contaminated Carina Sub-Acute Care Ventilators
In light of the recent voluntary recall initiated by Draeger Medical, Inc., for their Carina Sub-Acute Care Ventilators, many are questioning their legal options. The devices were found to have elevated levels of harmful contaminants, specifically affecting pediatric patients when used for extended periods. This article aims to offer a comprehensive guide for those interested in pursuing a civil lawsuit related to this medical device’s contamination.
Confirming Your Case: Product Identification
Your initial step should be to confirm whether your device is among the affected Carina ventilators. Check serial numbers, purchase dates, and any available documentation to establish the connection. Any diagnosis or medical records indicating health issues resulting from using the device should be carefully saved as they could be vital in building your case.
Accumulating Evidence: What You’ll Need
Once you’ve identified your device as one of the problematic units, begin collecting all relevant evidence. This includes, but is not limited to, medical records, purchase receipts, and correspondence with healthcare providers or the manufacturer. Photographic evidence of the device itself, especially showing serial numbers or other unique identifiers, can also strengthen your case.
Initial Consultation: Seek Legal Advice
Before filing a lawsuit, consult with one of our lawyers who focus their practice on product liability or medical malpractice cases. This step is crucial for understanding the legal terrain you’re about to navigate and for getting an expert opinion on the viability of your case. Your lawyer will also help you decide whether joining any existing class-action lawsuits might be more beneficial than filing a case independently.
Drafting and Filing the Complaint
With the help of your legal counsel, draft a formal complaint outlining the details of your case. This document serves as the basis for your lawsuit and should include the cause of action, the alleged harm, and the compensation sought. Once the complaint is prepared, your lawyer will file it in the appropriate court to officially commence legal proceedings.
Serving the Defendant and Next Steps
After the filing, Draeger Medical, Inc., or their legal representatives, must be served with a copy of the complaint. This action officially notifies them of the lawsuit. Following this, both parties enter the discovery phase, sharing relevant information and evidence. Settlement discussions may also take place at this point.
Filing a civil lawsuit in a case involving potentially harmful medical devices like the Carina Sub-Acute Care Ventilators is a complicated endeavor. Nevertheless, the legal system is in place to protect consumers and provide a means for compensation and justice. By consulting with a specialized attorney, you can make informed decisions on how to proceed with your case.
CONTACT PARKER WAICHMAN LLP FOR A FREE CASE REVIEW
Parker Waichman LLP helps families recover monetary compensation for harm caused by dangerous products like this defective product. For your free consultation, contact our national product liability law firm today by using our live chat or calling 1-800-YOUR-LAWYER (1-800-968-7529).
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