PlainRecalls
FDA Devices Critical Class I Ongoing

Iso-Gard Filter S, with Expandi-Flex, Tethered Cap, REF: a) 19261T, OUS only; b) 19262T, OUS only; c) 19272T, OUS only; Microbial medical gas filter, single-use,

Reported: October 26, 2022 Initiated: August 29, 2022 #Z-0075-2023

Product Description

Iso-Gard Filter S, with Expandi-Flex, Tethered Cap, REF: a) 19261T, OUS only; b) 19262T, OUS only; c) 19272T, OUS only; Microbial medical gas filter, single-use,

Reason for Recall

Incidents of device splitting or detaching during use

Details

Recalling Firm
TELEFLEX LLC
Units Affected
355 units
Distribution
US nationwide distribution
Location
Morrisville, NC

Frequently Asked Questions

What product was recalled?
Iso-Gard Filter S, with Expandi-Flex, Tethered Cap, REF: a) 19261T, OUS only; b) 19262T, OUS only; c) 19272T, OUS only; Microbial medical gas filter, single-use,. Recalled by TELEFLEX LLC. Units affected: 355 units.
Why was this product recalled?
Incidents of device splitting or detaching during use
Which agency issued this recall?
This recall was issued by the FDA Devices on October 26, 2022. Severity: Critical. Recall number: Z-0075-2023.