FDA-Device2022-10-26Class I
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.
TELEFLEX LLC
Hazard
Incidents of device splitting or detaching during use
Sold states
US nationwide distribution
Affected count
60,500 units US
Manufactured in
3015 Carrington Mill Blvd, N/A, Morrisville, NC, United States
Products
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 notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0072-2023Don't want to check this manually?
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