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Bacterial Viral Filter

MEDITERA TIBBI MALZEME SANAYI VE TICARET ANONIM SIRKETI · Model BV002 · UDI-DI 10850014574656

CAH Prescription

510(k) clearances

1,012

Adverse events (41 deaths)

Recalls

140

Facilities

Description

A device intended to be placed within a breathing circuit proximal to the patient, to remove and retain microbes whilst capturing the patient's exhaled heat and moisture so that they can be used to heat and humidify the therapeutic gases inspired by the patient. It is typically a plastic housing which contains both a bidirectional microbial filter, intended to reduce the risk of cross-contamination between patients, and a heat/moisture exchanger (HME), intended to maintain the mucous membranes of the respiratory tract. It is typically used during anaesthesia or periods of prolonged respiratory support/therapy. This is a single-use device.

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.