Teleflex Recalls Iso-Gard Filter S for Risk of Splitting, Detaching

The U.S. Food and Drug Administration (FDA) has identified Teleflex’s August 26 recall of its Iso-Guard Filter S as Class I, the most serious type of recall.
 
Iso-Gard Filter S filters are breathing circuit bacterial filters connected to respiratory equipment or breathing systems in intensive care units and operating rooms, They protect equipment and patients from potential airborne contaminants.
 
Teleflex recalled the filters after reports they may split or detach from breathing systems. If this occurs during use. The filter might not work correctly or efficiently and cause a patient to receive insufficient air supply and the patient’s oxygen levels may drop below the safe threshold. Potential cross-contamination may also occur.
 
60,500 devices were recalled in the U.S., distributed between September 1, 2020 and July 5, 2022. Reports indicate there have been 36 complaints and four injuries, including desaturation, related to the issue. No deaths or long-term injuries have been reported at the time of writing.
 
Further information about the recall can be accessed here.