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MADA MEDICAL PRODUCTS, INC.

MADA MEDICAL PRODUCTS, INC · Model 172BS-II · UDI-DI 00815160020559

BTA Prescription
10
510(k) clearances
1,061
Adverse events (29 deaths)
21
Recalls
98
Facilities

Description

An assembly of devices designed to evacuate fluid, tissue, gas, or other foreign materials from a body cavity or lumen by means of suction. It generally consists of a mains electricity (AC-powered) suction pump, tubing, plastic/glass collection container(s), a vacuum gauge, a vacuum control knob, an overflow trap, a moisture filter, and possibly a microbial filter. The pump creates a vacuum in the suction tubing, which is inserted into the body for the removal of materials into the collection container. This system can be used in a wide variety of settings within healthcare facilities.

Recalls

DateFirmReason
2023-08-23R A Medical ServicesInadequate documentation of acceptance activity
2021-11-16Ohio Medical CorporationIncrease in premature device failures
2020-12-02Medela AG Medical TechnologyIncorrect expiration date of "2023-07-24" on label of sterile tubing. Correct expiration date should be "2021-07-24".
2018-08-14Ohio Medical CorporationThe care-e-vac(R)3 Battery/AC Powered Portable Aspirator battery terminal may come in contact with the pump causing an electric short leading to damage to wiring and resulting in l
2016-02-08MicroAire Surgical Instruments, LLCComplaints that the cannula bent/broke during surgery.
2010-11-08Ohio Medical CorporationThe D-14 diode on the circuit board may fail, resulting in a damaged, overheated circuit board. Also a screw used to attach one of the feet of the unit may damage the battery insi
2010-05-10Ohio Medical CorporationOhio Medical has received a report of an explosive event with a MoblVac Portable Woundcare Pump housing where parts were separated while in an enclosed nylon transport bag during u
2010-05-10Ohio Medical CorporationOhio Medical has received a report of an explosive event with a MoblVac Portable Woundcare Pump housing where parts were separated while in an enclosed nylon transport bag during u
2008-08-07Smith And Nephew, Inc. Wound Management DivisionExternal battery chargers used with the Version 29 VISTA Negative Pressure Wound Therapy pumps are failing to properly charge the pump's battery.
2008-04-25Medtronic NeuromodulationThe Medela Vario 18 Vacuum Pump used with the Medtronic Bravo pH Monitoring System. The Vacuum Pump is used to provide the vacuum pressure during Capsule attachment. Some Medela

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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.