The company said it began notifying hospitals and distributors of the recall on May 14.
The FDA labeled it a Class I recall, the most serious type of recall issued by the federal watchdog, indicating that “there is a reasonable probability that use of these products will cause serious adverse health consequences or death.”
The device is being recalled because “the intake port may be blocked, which can cause the bag to fail to fill,” Teleflex said.
A total of 9,333 items are being recalled, with 42 lots and 5 product codes affected, the company said.
Three complaints have been received and no patient injuries have been reported, but delays in treatment to obtain another resuscitator could potentially lead to adverse events such as hypoxia, the Wayne, Penn.-based company said.
In February Teleflex expanded a Class I recall for Maquet Servo 163 humidifiers, which are used to warm and humidify gases inhaled through the throat by patients who have undergone a tracheotomy.
The initial humidifier recall, issued Dec. 4, 2014, covered only 3 lots of the product distributed in Florida, Kansas, Michigan and West Virginia from June 2013 through November 2014. The recall was expanded Jan. 12 to include 6 lots distributed in those states during that time.
The recall was issued over reports that cracks had been discovered in some of the devices, which could interfere with patients receiving sufficient amounts of gases such as oxygen, according to the FDA.