Draeger Medical Inc issued a voluntary recall for its Carina sub-acute care ventilators on July 12 due to the presence of contaminants in the device’s airpath, a recall the US Food and Drug Administration (FDA) now has identified as a Class I recall, the most serious type. Use of these devices may cause serious injuries or death.
According to a notice on FDA’s website, the contaminants exceed acceptable levels if used by pediatric patients for more than 30 days. During testing, the firm found polyether polyurethane 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.
Draeger will be updating affected devices to address this issue. Clinicians may continue to use the devices with adult patients and are instructed not to 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 Oct 30, 2023
- Devices Recalled in the US: 703
- Date Initiated by Firm: July 12
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
Recommendations for Affected Customers
On July 12, Draeger 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 US with questions about this recall should contact Draeger Service Technical Support at 1-800-437-2437 (press 2 at the prompt, then 2 again).