FDA-Device2022-10-26Class I
Iso-Gard Filter S, with Expandi-Flex, REF: a) 19261, OUS only; b) 19272, 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
7 units
Manufactured in
3015 Carrington Mill Blvd, N/A, Morrisville, NC, United States
Products
Iso-Gard Filter S, with Expandi-Flex, REF: a) 19261, OUS only; b) 19272, OUS only; Microbial medical gas filter, single-use
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0073-2023Don't want to check this manually?
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