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EvaQMax Laparo

BIOPROTECH INC. · Model ASF3 · UDI-DI 08809083944803

GAZ Prescription
10
510(k) clearances
306
Adverse events
14
Recalls
206
Facilities

Description

Active Volume Control, Active Laparoscopic Smoke Filtration Device, Volume controller, Filtration, Fluid trap 10 Ft(3M) hose

Recalls

DateFirmReason
2025-01-31DeRoyal Industries IncDue 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
2017-10-24Medtronic Minimally Invasive Therapies GroupIncorrect 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
2016-06-27ConMed CorporationThe packaging seal may contain a crease. The crease may result in an open channel. These channels may compromise sterility of the product.
2010-08-16Cardinal HealthThe packaging seals may not be intact, resulting in compromised sterility for the listed Medi-Vac Non-Conductive Tubing.
2010-08-16Cardinal HealthThe packaging seals may not be intact, resulting in compromised sterility for the listed Medi-Vac Non-Conductive Tubing.
2010-08-16Cardinal HealthThe packaging seals may not be intact, resulting in compromised sterility for the listed Medi-Vac Non-Conductive Tubing.
2010-08-16Cardinal HealthThe packaging seals may not be intact, resulting in compromised sterility for the listed Medi-Vac Non-Conductive Tubing.
2010-08-16Cardinal HealthThe packaging seals may not be intact, resulting in compromised sterility for the listed Medi-Vac Non-Conductive Tubing.
2010-08-16Cardinal HealthThe packaging seals may not be intact, resulting in compromised sterility for the listed Medi-Vac Non-Conductive Tubing.
2010-08-16Cardinal HealthThe 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.