FDA recall Z-0072-2023

Product

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.

Reason for recall

Incidents of device splitting or detaching during use

Distribution

US nationwide distribution

Key facts

Status

Ongoing

Initiation date

2022-08-29

Report date

2022-10-26

Voluntary/Mandated

Voluntary: Firm initiated

Location

Morrisville, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0072-2023