Teleflex Filter Recall is Class 1

FDA says the Teleflex 8/26 recall of 60,000 Iso-Gard Filter S products is Class 1. An agency notice says the breathing circuit bacterial filters are connected to respiratory equipment or breathing systems in intensive care units and operating rooms.

The recalled units were distributed between 9/1/20 and 7/5/22.

Teleflex recalled several types of the filters after receiving reports that the filters may split or detach from breathing systems. The notice says that if the filter splits or detaches during use, it may not work properly or efficiently. “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, as well as potential cross-contamination,” the agency says.

Teleflex says there have been 36 complaints and four injuries related to the issue. There have been no reports of deaths or long-term injuries, it says.