FDA-Device2022-10-26Class I
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
TELEFLEX LLC
Hazard
Incidents of device splitting or detaching during use
Sold states
US nationwide distribution
Affected count
42 units
Manufactured in
3015 Carrington Mill Blvd, N/A, Morrisville, NC, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0076-2023Don't want to check this manually?
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