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RespVent™

CUTTING EDGE HC BRANDS LLC · Model RTG-01101 · UDI-DI 00850108006103

CAH Prescription

510(k) clearances

1,004

Adverse events (41 deaths)

Recalls

140

Facilities

Description

RespVent HEPA Bacteria Viral Respiratory Filter is a disposable single-use device indicated for patient during the delivery of ventilator gases. They provide filtration for reducing possible cross contamination between patient and equipment. The RespVent Filter is for use in hospital, ICU, anesthesia, respiratory therapy, during transport and with resuscitators. The RespVent Filter can be used on adult patients. The RespVent Filter is indicated for use by qualified medical personnel only. The RespVent Filter is designed for disposable use and should be changed at least every 24 hours.

Recalls

Date	Firm	Reason
2025-10-10	Medline Industries, LP	Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inad
2025-06-16	Draeger, Inc.	Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.
2025-06-16	Draeger, Inc.	Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.
2025-06-16	Draeger, Inc.	Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.
2025-06-16	Draeger, Inc.	Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.
2025-01-09	Kung Shin Plastics Co. Ltd.	The machine side connector of the filter HME may be occluded by plastic which prevents proper airflow. The issue may lead to ventilation bag malfunction in which the user is unable
2025-01-09	Kung Shin Plastics Co. Ltd.	The machine side connector of the filter HME may be occluded by plastic which prevents proper airflow. The issue may lead to ventilation bag malfunction in which the user is unable
2024-04-08	MEDLINE INDUSTRIES, LP - Northfield	Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that ma
2023-07-18	Smiths Medical ASD Inc.	Smiths Medical identified a labeling error in which the barcode (UDI) was not correctly reflecting the expiration date of the product
2023-01-05	S & MOHR AMERICA, S.A. DE C.V.	Incorrect expiration date on product label. The manufacturing date was listed as the expiration date. Correct expiration date is "22.07.2027"

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.