FDA Categorizes Draeger Medical’s Pediatric Ventilator Recall as Most Severe
Key Points:
- 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
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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).
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