|Soft Flex and Corrugated Flex tubes--Courtesy of Teleflex Medical|
The woes of German devicemaker Maquet Holding continue. Just days after the Department of Justice slapped it with a permanent injunction due to product safety issues, the FDA rapped its Servo Humidifier 163 with two Class I recalls.
This time around, Maquet is only the distributor. The product is manufactured by Teleflex Medical, but is distributed by Maquet under the Servo brand, a Maquet representative told FierceMedicalDevices.
The Class I designation means that there is a reasonable probability that using the Servo "will cause serious adverse health consequences or death," according to the FDA.
The agency says the problem with the device is that "cracks may occur in the corrugated flex tube of the 15 mm and 22 ISO female connector." The Servo is used to warm and humidify gases, but it is not an ordinary humidifier. This one is positioned over surgically created opening in the throat (a tracheotomy) or the tracheal tube that is inserted into the trachea.
Another recall of the Servo, which appears similar, was issued against and Arrow International, which was acquired by Teleflex in 2007. In the case of Servos recalled by Arrow International, the FDA says that the cracking may lead to leaks, adding "if a leak exists and is left untreated, the patient may be deprived of adequate anesthetic gases over a period of time and serious adverse health consequences may occur."
A total of 118 Servos are affected.
The recall notice contains the affected batch numbers. Letters requesting customers to return the defective devices to their local Maquet representative were sent in December and January.
When announcing the permanent injunction, the FDA said it had overseen 45 recalls of Maquet devices and repeatedly citing it for violations of the Quality System good manufacturing regulation, Medical Device (adverse event) Reporting regulation, and others.
"Patients must be assured that medical devices are safe, effective and high quality," said Jan Welch, acting director of the Office of Compliance in the FDA's device arm (CDRH), in the statement announcing the injunction. "The FDA will remain vigilant in bringing companies that do not meet our regulatory requirements back to a sustainable state of compliance."
Editor's Note: This article was corrected so that it accurately identified the manufacturer and the distributor.