AXS Universal Liner Set
Medela AG · Model 077.0194 · UDI-DI 07612367054959
BTA
Prescription
10
510(k) clearances
1,027
Adverse events (29 deaths)
21
Recalls
99
Facilities
Description
The Medela Disposable Collection System is suitable for the safe collection and disposal of suctioned fluids.
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.