Teleflex’s recall of bacterial filters has been labeled a Class I event by the Food and Drug Administration, which warned that continued use of the product “may cause serious injuries or death.”
The Wayne, Penn.-based company’s Gibeck Iso-Gard Filter S devices are bacterial filters that are connected to respiratory equipment or breathing systems in intensive care units and operating rooms, the FDA said in a statement on Thursday. The filters protect equipment and patients from potential airborne contaminants.
The agency said Teleflex is recalling “several types” of the ISO-Gard Filter S after receiving reports that the filters may split or detach from breathing systems and fail to work properly.
“The issue may cause a patient to receive an insufficient supply of air and for the patient’s oxygen levels to drop below safe levels (desaturation), as well as potential cross-contamination. Use of these devices may cause serious injury or death,” the FDA wrote.
“As of October 6, 2022, a total of 38 complaints reporting the filter splitting or detaching have been received for the products in scope of this recall. Of these 38 complaints, 4 complaints reported injuries, including patient desaturation. No deaths or long-term patient injuries have been reported at this time,” Teleflex said in its own statement on Thursday announcing the recall.
Teleflex said it began the recall on Aug. 26 and that the FDA marked it as a Class I event on Oct. 14. No reason was given by either Teleflex or the FDA for the delay in making a public announcement.
The recall affects 60,500 products distributed across the U.S., according to an FDA database.
