There are more recalls on the horizon for ventilator-related technologies. FDA said Tuesday, Draeger faces a Class I recall for 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.
The recall impacts nearly 36,000 ventilator filters.
If the filter on a ventilator or breathing system is obstructed, oxygen may not flow properly to the patient. There has been one complaint and one injury associated with the use of this device. There have been no reported deaths.
Draeger issued an Urgent Medical Device Recall letter to customers who may have received filters from the affected lot, on May 16.
A significant number of ventilators have been recalled throughout the past few years. Late last year, Medtronic experienced a Class I recall for its Puritan Bennett 980 Series Ventilator.
The Dublin-based company inherited the ventilators when it acquired Covidien for $43 billion. In 2014, prior to the acquisition, Covidien faced a recall involving a dimming screen and burning smell coming from the Puritan Bennet 980.
And a little more than a year ago, it was reported some of Philips’s ventilators and sleep apnea machines faced a massive recall. The company also faces multiple lawsuits regarding the issue.
