Recall Z-0073-2023— TELEFLEX LLC

Name: FDA recall Z-0073-2023
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, with Expandi-Flex, REF: a) 19261, OUS only; b) 19272, OUS only; Microbial medical gas filter, single-use. 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, with Expandi-Flex, REF: a) 19261, OUS only; b) 19272, OUS only; Microbial medical gas filter, single-use

Reason for recall

Incidents of device splitting or detaching during use

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