Sam Brusco, Associate Editor06.21.22
The U.S. Food and Drug Administration (FDA) has named Dreger’s recall of the SafeStar 55 breathing system filter as Class I.
35,950 devices distributed between August and October 2021 were recalled in the U.S., beginning on May 9 of this year. Thus far, there has been one complaint and one injury associated with the device’s use, and no reported deaths.
The SafeStar 55 breathing system filter is used as part of a ventilator when a patient is under anesthesia or needs assistance breathing. It’s meant to reduce contaminants like bacteria, other micro-organisms, and small particles that can reach a patient receiving breathing support from the ventilator.
A specific lot (LT2103) was recalled because a manual inspection led to some defective filters, including some that could be partially obstructed, to be inadvertently distributed instead of destroyed. If these filters are obstructed on a ventilator or a breathing system, oxygen may not flow properly to the patient. The resulting hypoxia can have serious effects, including death.
Customers were urged to check stock for filters with the LT2013 lot number and segregate or quarantine any filters with the lot number listed. Customer service could be contacted to replace affected filters free of charge and receive prepaid shipping to return defective filters.
35,950 devices distributed between August and October 2021 were recalled in the U.S., beginning on May 9 of this year. Thus far, there has been one complaint and one injury associated with the device’s use, and no reported deaths.
The SafeStar 55 breathing system filter is used as part of a ventilator when a patient is under anesthesia or needs assistance breathing. It’s meant to reduce contaminants like bacteria, other micro-organisms, and small particles that can reach a patient receiving breathing support from the ventilator.
A specific lot (LT2103) was recalled because a manual inspection led to some defective filters, including some that could be partially obstructed, to be inadvertently distributed instead of destroyed. If these filters are obstructed on a ventilator or a breathing system, oxygen may not flow properly to the patient. The resulting hypoxia can have serious effects, including death.
Customers were urged to check stock for filters with the LT2013 lot number and segregate or quarantine any filters with the lot number listed. Customer service could be contacted to replace affected filters free of charge and receive prepaid shipping to return defective filters.