The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
Please be aware, this recall is a voluntary correction, not a product removal.
Draeger will be updating affected devices to address this issue.
Clinicians may continue to use the devices with adult patients and are instructed to not use the devices with pediatric patients.
- Product Name: Carina Sub-Acute Care Ventilator
- Product Codes: See Recall Database Entry
- Model Numbers: Part Number 5704110, UDI Number 04048675398516, all serial numbers
- Distribution Dates: March 16, 2009 to October 30, 2023
- Devices Recalled in the U.S.: 703
- Date Initiated by Firm: July 12, 2023
The Carina Sub-Acute Care Ventilator is used for people who require full or partial breathing assistance from a mechanical ventilator inside a hospital. The ventilator can be used for invasive (trachea tube) or non-invasive (mask) ventilation.
Reason for Recall
Draeger Medical, Inc. is recalling its Carina Ventilators due to the presence of contaminants in the device’s airpath. The contaminants exceed acceptable levels if used by pediatric patients for more than 30 days. During testing, the firm found polyether polyurethane (PE-PUR) in the airpath of the Carina ventilator. This results in the emission of contaminant 1,3-Dichloropropan-2-ol, a potential carcinogen.
The use of Carina Sub-Acute Care Ventilators in pediatric patients may cause serious adverse health consequences, including exposure to hazardous chemicals, toxic reactions, and death.
There have been no reported deaths, complaints, or incidents associated with this issue.
Who May be Affected
- Children who receive breathing support from Carina Sub-Acute Care Ventilators
- Health care providers who provide breathing support care for pediatric patients with Carina Sub-Acute Care Ventilators
What to Do
On July 12, 2023, Draeger Medical Inc. sent all affected customers an Urgent Medical Device Recall Letter with the following recommendations:
- Users of the Carina ventilator may continue use until it is modified, if the following conditions are met:
- Ensure that the set minute volume exceeds 3.6 l/min
- Only ventilate adult patients
- Only use a Draeger ventilation hose with leak valve
- Use an inline bacterial filter as described in the Instructions for Use
Customers in the U.S. with questions about this recall should contact Draeger Service Technical Support between the hours of 8:00 AM – 8:00 PM ET at 1-800-437-2437 (press 2 at the prompt, then 2 again).
Additional information from Draeger regarding this issue can be found on their website: https://www.draeger.com/en-us_us/Newsroom/Press-Center.
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.