Recall Z-0072-2023— TELEFLEX LLC

Name: FDA recall Z-0072-2023
Creator: U.S. Food and Drug Administration
Published: 2022-08-29

Class I · Ongoing

Class I FDA medical device recall by TELEFLEX LLC, initiated 2022-08-29. It names one FDA 510(k) clearance: K965016. 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: Incidents of device splitting or detaching during use.

Recalling firm: TELEFLEX LLC
Classification: Class I
Status: Ongoing
Initiated: 2022-08-29
Firm location: Morrisville, NC, United States

510(k) clearances named in this recall

1 on FDA's record

K965016 — ISO-GARD FILTER ANGLED(18212)/ISO-GARD FILTER STRAIGHT(19212)Gibeck, Inc.·cleared 1997-12-02

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.