FDA Issues Update on Teleflex Filter Recall
The FDA has issued an update on Teleflex’s Aug. 26 recall of its Iso-Gard Filter S breathing filter devices, designating it a Class 1 because of the risk of serious injury or death.
The bacterial filters, which connect to respiratory equipment or breathing systems in intensive care units and operating rooms, are intended to protect the equipment and the patients from airborne contaminants.
The company has received reports that the filters may split or detach from breathing systems, leading to the patient receiving an insufficient supply of air, the FDA said.
The 60,500 affected filters were distributed between Sept. 1, 2020 and July 5. Teleflex has reported 36 complaints and 4 injuries related to this issue, but no deaths or long-term injuries, the agency said.