- The FDA announced Tuesday that medical device maker Teleflex Incorporated ( NYSE: TFX ) is recalling more than 2.7M of its Iso-Gard Filter S filters in the U.S. after receiving reports that the bacterial filters may split or detach from breathing systems.
- The FDA said the company had cited 36 complaints and four injuries related to the issue and added that there were no reports of deaths or long-term injuries. The agency has classified the recall as a Class I, the most serious type.
- Iso-Gard Filter S are microbial filters used in intensive care units and operating rooms to protect equipment and patients from airborne contaminants.
For further details see:
Teleflex recalls over 2.7M bacterial filters – FDA