FDA recall Z-0076-2023

Product

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

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-0076-2023