FDAAugust 29, 2022device

Iso-Gard Filter S, REF : a) 19211, OUS only; b) 19212; Microbial medical gas filter, single-use. Bacterial/viral filters for use in breathing system for the protection of patient and equipment.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Incidents of device splitting or detaching during use

What to do

FDA enforcement status: Ongoing

Brands named

teleflex

UPCs

04026704347995

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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