Dräger Inc is recalling approximately 35,000 if its SafeStar 55 Breathing System Filters due to the potential for the filters to be defective, including some that may be partially obstructed, according to an FDA alert. The SafeStar 55 is used as part of a ventilator when a patient is under anesthesia or needs breathing assistance, the FDA said.
The agency warned that if the SafeStar 55 filter on a ventilator or breathing system is obstructed, oxygen may not flow properly to the patient and can lead to hypoxia, which can have serious effects, including death.
According to the FDA, it is a Class I recall, and there has been one complaint and one injury associated with the use of this device, but no reported deaths.
The agency said a manual inspection process led the devices in a specific lot (LT2103) to be inadvertently distributed instead of destroyed.
Recalled Product Info
- Product Name: SafeStar 55 Breathing System Filter
- Product Model Numbers: MP01790
- Lot Number: LT2103
- Devices Recalled in the U.S.: 35,950
- Dates distributed: August 18, 2021, to October 12, 2021
- Date Initiated by Firm: May 9, 2022
On May 16, 2022, Dräger issued an Urgent Medical Device Recall letter to customers who may have received SafeStar 55 filters from the affected lot (LT2103).
The letter requested customers to:
- Check stock for filters with the lot number LT2103
- Segregate/quarantine any filters with the lot number listed.
- Contact Dräger Customer Service to replace affected filters free of charge and to receive pre-paid shipping to return affected filters:
- Phone between the hours of 8:00 AM – 8:00 PM EST Monday thru Friday at 1-800-437-2437 (press 2 at the prompt, then 1)
- Fax: 1-215-723-5935, or
- Email: [email protected]
- Notify any other affected parties about this issue, including third parties who may have received this device.
- Return a Customer Acknowledgement form to confirm receipt of the information and that stock has been checked.
Customers with questions or concerns about this recall should contact Michael Kelhart at Draeger, Inc between the hours of 8:00 AM – 4:30 PM EST at 1-800-437-2437 (press 1 at the prompt, then 32349).