FDA Categorizes Draeger Medical’s Pediatric Ventilator Recall as Most Severe
- FDA identifies Draeger Medical’s Carina Sub-Acute Care Ventilator for children as a Class I recall.
- Ventilators remain viable for adult use under specific conditions.
- The recall stems from the risk of toxic exposure due to contaminants in the device’s airpath.
The U.S. Food and Drug Administration (FDA) has classified the recent recall of Draeger Medical’s Carina Sub-Acute Care Ventilators designed for pediatric use as a Class I recall, indicating the highest level of risk.
Instead of pulling the affected devices off the market entirely, Draeger Medical plans to revise or repair the ventilators involved in the recall, as per FDA’s announcement.
The Carina Sub-Acute Care Ventilators are commonly used in hospitals to assist patients requiring mechanical breathing support.
The basis for the recall revolves around the presence of impurities, such as polyether polyurethane, in the airflow mechanism of the ventilator. According to FDA’s warning, these impurities could accumulate to harmful levels if the device is operated for an extended period, surpassing 30 days. Such exposure could result in adverse chemical reactions, toxic effects, or even fatality.
The recall specifically targets 703 units within the United States. As of now, there have been no reported incidents or deaths linked to the issue, as confirmed by Draeger Medical to the FDA.
In July 2023, the medical device manufacturer issued an Urgent Medical Device Recall letter to users. The communication clarified that the device can still be deployed for adult patients under particular stipulations. The guidelines include:
- Maintaining a set minute volume above 3.6 L per minute.
- Using a Draeger-specific ventilator hose equipped with a leak valve.
- Incorporating an inline bacterial filter in accordance with the device’s instruction manual.
This is not the first time Draeger Medical has been involved in a Class I recall by the FDA. As reported earlier, the company was subjected to a similar recall last month, focusing on its Oxylog 3000 Plus Emergency and Transport Ventilator.
The FDA’s Class I designation underlines the seriousness of the potential health risks and underscores the importance of adhering to the updated guidelines for the device’s safe usage.
Initiating the Claims Process with Parker Waichman LLP: A Step-by-Step Guide
Starting a legal claims process can be overwhelming, especially when you’re dealing with stressors that typically prompt a lawsuit in the first place. If you’ve decided to work with Parker Waichman LLP for your legal concerns, the following guide outlines the steps you should take to begin the claims process smoothly.
Step 1: Initial Consultation
Contact Parker Waichman LLP to set up an initial consultation. This initial meeting is usually free of charge and gives you an opportunity to discuss your case’s specifics. You can reach out via phone, email, or through their website’s contact form.
Step 2: Documentation
Gather all relevant documentation. This could include medical records, accident reports, contracts, or any other records related to your case. Having all of this information ready will streamline the initial review process.
Step 3: Case Evaluation
Undergo a case evaluation. The attorneys at Parker Waichman LLP will assess the strength of your case based on the information and documents you provide. They will help you understand the likelihood of a successful outcome and what compensation you might expect.
Step 4: Retainer Agreement
Sign a retainer agreement. If both parties agree to proceed, you’ll need to sign a retainer agreement, which outlines the terms of the legal representation, including fee structures and responsibilities.
Step 5: Investigation
Participate in the investigative process. Your attorney will likely need additional details, interviews, or documents. Be prepared to provide more information and cooperate fully with their investigation to build a strong case.
Step 6: Pre-Litigation Steps
Follow the pre-litigation process. Depending on your case, there might be attempts to settle before going to court. This could involve negotiation, mediation, or arbitration. Your attorney will guide you through these options and represent your interests throughout.
Step 7: Litigation
Engage in litigation, if necessary. If a pre-court settlement isn’t possible or favorable, your attorney will prepare for litigation. This involves filing the necessary documents, gathering evidence, and representing you in court.
Step 8: Settlement or Judgment
Await the settlement or court judgment. Once the legal process is underway, it could take time for a settlement to be reached or for a court to render a judgment. During this time, maintain open communication with your attorney for updates.
Step 9: Closure
Close the case and proceed with compensation. Whether you win or lose, there will be steps to close out the case, including disbursements if you win. Your attorney will guide you through these final steps.
Step 10: Review
Conduct a post-case review. After the case concludes, it’s beneficial to meet with your attorney for a debrief, discussing what went well and any lessons for the future.
Initiating a claims process is a significant undertaking, but with professional guidance from a firm like Parker Waichman LLP, you can navigate it with greater confidence. Always remember to maintain open, honest communication with your attorney throughout the process for the best possible outcome.
If you or a loved one has been adversely affected by a medical device, such as the recently recalled Draeger Medical Carina Sub-Acute Care Ventilator, you may be eligible for compensation. Don’t navigate this complex legal landscape alone. Call the experienced attorneys at Parker Waichman LLP today. With a national practice and proven track record, we’re here to advocate for your rights and seek the justice you deserve. Reach out for your free initial consultation at our toll-free number 1-800-YOURLAWYER (1-800-968-7529) and take the first step toward resolution.
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).
New York | Brooklyn | Queens | Long Island | New Jersey | Florida
Call us at: 1-800-YOURLAWYER (800-968-7529) | Schedule your free consultation