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HarmonyAIR

STERIS CORPORATION · Model Smoke Evacuator Filter Fluid Trap · UDI-DI 10724995150119

GAZ

510(k) clearances

344

Adverse events

Recalls

208

Facilities

Description

The HarmonyAIR Smoke Evacuator Filter Fluid Traps is a box of 10 filter fluid traps for the HarmonyAIR Smoke Evacuator that is designed to capture fluids to help maintain the integrity of the filtration system and assist with maintaining filter life.

Recalls

Date	Firm	Reason
2025-01-31	DeRoyal Industries Inc	Due to the inner diameter of the suction tubing connector being smaller than the suction canister lid port connection. This size difference, combined with the durometer of the plas
2017-10-24	Medtronic Minimally Invasive Therapies Group	Incorrect packaging. In one lot of Argyle Suction Tubing, the pouch may be incorrectly labeled as the Salem Sump Dual Lumen Stomach Tube. This product may have been distributed wit
2016-06-27	ConMed Corporation	The packaging seal may contain a crease. The crease may result in an open channel. These channels may compromise sterility of the product.
2010-08-16	Cardinal Health	The packaging seals may not be intact, resulting in compromised sterility for the listed Medi-Vac Non-Conductive Tubing.
2010-08-16	Cardinal Health	The packaging seals may not be intact, resulting in compromised sterility for the listed Medi-Vac Non-Conductive Tubing.
2010-08-16	Cardinal Health	The packaging seals may not be intact, resulting in compromised sterility for the listed Medi-Vac Non-Conductive Tubing.
2010-08-16	Cardinal Health	The packaging seals may not be intact, resulting in compromised sterility for the listed Medi-Vac Non-Conductive Tubing.
2010-08-16	Cardinal Health	The packaging seals may not be intact, resulting in compromised sterility for the listed Medi-Vac Non-Conductive Tubing.
2010-08-16	Cardinal Health	The packaging seals may not be intact, resulting in compromised sterility for the listed Medi-Vac Non-Conductive Tubing.
2010-08-16	Cardinal Health	The packaging seals may not be intact, resulting in compromised sterility for the listed Medi-Vac Non-Conductive Tubing.

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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.