- Company Announcement Date:
- August 01, 2023
- FDA Publish Date:
- August 04, 2023
- Product Type:
- Medical Devices
- Reason for Announcement:
Recall Reason Description
Product Safety/Potential Foreign Material
- Company Name:
- Drägerwerk AG & Co. KGaA
- Brand Name:
- Product Description:
Carina Sub-Acute Care Ventilators
Drägerwerk AG & Co. KGaA initiated a voluntary recall notification for Dräger Carina Sub- Acute Care Ventilators to address possible contamination of the breathing gas with 1,3- Dichloropropan-2-ol, a constituent of the PE-PUR foam used for sound insulation. To date, Dräger’s market surveillance activities show that no complaints relating to this problem have been reported.
To determine the long-term stability of the polyether polyurethane (PE-PUR) foam used for sound insulation in Carina ventilators, Dräger subjected devices of different ages to biocompatibility tests. For Carina ventilators operated for periods of up to 15 years, no age-related degradation or decay products associated with degradation were found in those standard tests.
However, certain standard tests conducted by Dräger measured concentrations of 1,3-Dichloropropan- 2-ol above the acceptable uptake level during continuous use (>30 days) in pediatric patients. Dräger’s investigations determined that a setting of higher minute volumes leads to lower concentrations in the breathing air. At a minute volume greater than 3.6 l/min, the measured concentrations were in the acceptable range for continuous use in adult patients.
1,3-Dichloropropan-2-ol is a constituent of the polyurethane foam, which was not discovered in the breathing gas during previous biocompatibility tests conducted within the framework of product approvals and modifications.
Potential Patient Impact
In literature, 1,3-Dichloropropan-2-ol is considered to be acutely toxic and a potential carcinogen. Potential risks of chemical exposure due to off-gassing include: headache/dizziness, irritation (eyes, nose, respiratory tract, skin), hypersensitivity, nausea/vomiting, toxic and carcinogenic effects. There have been no reports of death as a result of such exposure.
These issues may result in serious injury, which can be life-threatening, cause permanent impairment, and/or require medical intervention to preclude permanent impairment. To date, Dräger has not received any reported symptoms of an acute toxic reaction, nor any other complaints relating to this issue via our market surveillance.
Although Dräger discontinued production of the Carina ventilator in 2019, the company is planning to remove the foam from Carina ventilators still in use and replace with a newly designed blower cover, without additional foam, for noise reduction purposes.
Worldwide, the Carina ventilator was distributed to customers by Dräger Sales and Service entities. The Carina ventilator was manufactured from November 1, 2006, through November 30, 2019.
In the U.S., the Carina ventilator was distributed from March 16, 2009, through October 20, 2012. Outside the U.S., the Carina ventilator was distributed from May 23, 2007, through February 3, 2022.
Only the products listed below (all serial numbers) are included in the voluntary recall:
|Product Name||Part Number||UDI Number|
|Dräger Carina Sub-Acute Care Ventilator||5704110||04048675398516|
Carina ventilator customers may continue using the devices until they have been modified, provided the following conditions are met:
- the set minute volume exceeds 3.6 l/min;
- only adult patients are ventilated;
- only a ventilation hose with Dräger leak valve is used; and
- an inline bacterial filter is used in accordance with the Instructions for Use.
According to current planning, the newly designed blower cover will be available in the early part of the fourth quarter of 2023. Once available, the local Dräger Service representative will contact Carina customers to schedule a time for the update to be carried out free of charge. Dräger estimates that all devices still in use will be updated within 8 months of the update being available.
Once the Carina ventilator has been updated, it can be used again as normal. The modification will not change the overall function of the Carina ventilator.
Affected customers have been notified and sent a Return Response Acknowledgment and Receipt Form to complete and return to Dräger.
Customers were asked to ensure that all users and maintenance staff of the Carina ventilator within their organization were made aware of the Recall Notice, keep the information until the modification has been completed, and instructed to forward the information if the product was made available to third parties.
In the U.S., if you have any questions regarding the operation of your Carina ventilator, please contact Dräger Service Technical Support between the hours of 8:00 AM – 8:00 PM EST at 1-800-437-2437 (press 2 at the prompt, then 2, then 2 again).
If you have any questions regarding this Urgent Medical Device Recall notice, please contact Michael Kelhart between the hours of 8:00 AM – 4:30 PM EST at 267-664-1131 or via email at [email protected].
Outside the U.S., if you have any questions regarding the operation of your Carina ventilator or have questions regarding this recall, please contact your local Dräger representative.
This voluntary medical device recall has been reported to the FDA.
- Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Complete and submit the report online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Dräger. Technology for Life®
Dräger is an international leader in the fields of medical and safety technology. Our products protect, support, and save lives. Founded in 1889, Dräger generated revenues of around EUR 3 billion in 2022. The Dräger Group is currently present in over 190 countries and has more than 16,000 employees worldwide. For more information, visit www.draeger.com.