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GOMCO
Allied Medical, LLC · Model 01-63-3040 · UDI-DI 00026072002155
BTA
Prescription
1
510(k) clearances
968
Adverse events (29 deaths)
21
Recalls
99
Facilities
Description
ASPIRATOR STAND MOUNTED,220V/50Hz
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-08-23 | R A Medical Services | Inadequate documentation of acceptance activity |
| 2021-11-16 | Ohio Medical Corporation | Increase in premature device failures |
| 2020-12-02 | Medela AG Medical Technology | Incorrect expiration date of "2023-07-24" on label of sterile tubing. Correct expiration date should be "2021-07-24". |
| 2018-08-14 | Ohio Medical Corporation | The 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 |
| 2016-02-08 | MicroAire Surgical Instruments, LLC | Complaints that the cannula bent/broke during surgery. |
| 2010-11-08 | Ohio Medical Corporation | The 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 |
| 2010-05-10 | Ohio Medical Corporation | Ohio 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 |
| 2010-05-10 | Ohio Medical Corporation | Ohio 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 |
| 2008-08-07 | Smith And Nephew, Inc. Wound Management Division | External battery chargers used with the Version 29 VISTA Negative Pressure Wound Therapy pumps are failing to properly charge the pump's battery. |
| 2008-04-25 | Medtronic Neuromodulation | The 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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Get your free API keyRead the docsData 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.