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.
- 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
The Draeger, Inc SafeStar 55 is a breathing system filter that is used as part of a ventilator when a patient is under anesthesia or needs breathing assistance. The SafeStar 55 Breathing System Filter is intended to reduce the contaminants like bacteria, other micro-organisms, and small particles, that reach a patient who is receiving breathing support from the ventilator.
Reason for Recall
Draeger, Inc is recalling a specific lot (LT2103) of the SafeStar 55 Breathing System Filter because a manual inspection process led to some defective filters, including some that may be partially obstructed, to be inadvertently distributed instead of destroyed.
If the filter on a ventilator or breathing system is obstructed, oxygen may not flow properly to the patient. That lack of oxygen (hypoxia) can have serious effects including death.
There has been one complaint and one injury associated with the use of this device. There have been no reported deaths.
Who May Be Affected
- Health care personnel who use Draeger SafeStar55 Breathing System Filters as part of a ventilator or breathing system for patients including patients receiving anesthesia
- People who receive breathing support or anesthesia using a ventilator or breathing system that includes Draeger SafeStar55 Breathing System Filters
What to Do
On May 16, 2022, Draeger issued an Urgent Medical Device Recall letter to customers who may have received filters from the affected lot.
The letter requested customers to:
- Check stock for filters with the lot number LT2103
- Segregate/quarantine any filters with the lot number listed.
- Contact Draeger 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: US-Medical@draeger.com.
- 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).
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.