FDA-Device2022-10-26Class I

Iso-Gard Filter S, Tethered Cap, REF: a) 19211T, OUS only; b) 19212T, 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
164 units
Manufactured in
3015 Carrington Mill Blvd, N/A, Morrisville, NC, United States
Products
Iso-Gard Filter S, Tethered Cap, REF: a) 19211T, OUS only; b) 19212T, OUS only; Microbial medical gas filter, single-use

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0074-2023

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