United States
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. 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.
The recalled product is:
- Dräger Carina Sub-Acute Care Ventilator, Part Number: 5704110, UDI Number: 04048675398516.
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.
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.
Company name: Drägerwerk AG & Co. KGaA
Brand name: Dräger
Product recalled: Carina Sub-Acute Care Ventilators
Reason of the recall: Product Safety/Potential Foreign Material
FDA Recall date: August 04, 2023
Source:
www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/drager-issues-worldwide-voluntary-recall-notification-carina-sub-acute-care-ventilators-address
