U.S. health regulators on Tuesday classified the recall of Teleflex Inc.’s Iso-Gard filter S, a medical device to protect patients from potential airborne contaminants, as most serious, saying its use could lead to injuries or death.
The company recalled some models of the filter in August, after receiving reports of it splitting and getting detached from patients’ respiratory devices during use, which may lead to insufficient supply of air for patient as well as potential cross-contamination.
It had recalled about 2.7 million filters distributed between Sept. 1, 2020 to July 5, 2022.
The company did not immediately respond to Reuters request for comment on the impact from the recall.
There have been 36 complaints and 4 injuries, no reports of deaths or long-term injuries associated with the use of the product, the Food and Drug Administration (FDA) said on Tuesday.
