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TELEFLEX LLC recalls Iso-Gard Filter S with Expandi-Flex/Elbow: a) REF 19012, OUS only, b) REF 19012T with Tethered Cap, OUS only; Microbial
Recalled October 26, 2022 · FDA recall Z-0076-2023 · TELEFLEX
Hazard
Incidents of device splitting or detaching during use · FDA Class I
Units
42 units
Sold at
US nationwide distribution
Description
Incidents of device splitting or detaching during use
Product
Iso-Gard Filter S with Expandi-Flex/Elbow: a) REF 19012, OUS only, b) REF 19012T with Tethered Cap, OUS only; Microbial medical gas filter, single-use
Manufacturer(s)
TELEFLEX LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →