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Hands-Free Double Pumpset

Ardo medical AG · Model 63.00.454 · UDI-DI 07640108054494

HGX
1
510(k) clearances
5,563
Adverse events (2 deaths)
8
Recalls
118
Facilities

Description

The Ardo Hands-Free Double Pumpset should be used in combination with the Ardo breastpumps and is intended for the expression and collection of breast milk. The pumpset can be used as a single or double pumpset.

Recalls

DateFirmReason
2017-07-10AMEDA, INC.Two specific lots was incorrectly manufactured containing a UK power adapter.
2014-03-18Energizer Personal CareSome of the power adapters outer casings may become loose and separate, resulting in a potential for electric shock.
2011-01-10Medela IncThe performance of the pumps may be compromised due to the potentiometer used on the circuit board. Affected pumps may not turn on, may turn off on its own, may reduce or lose suc
2010-08-06Medela IncThe product sterility may be compromised due to possible pinholes in the rigid tray of the package.
2010-08-06Medela IncThe product sterility may be compromised due to possible pinholes in the rigid tray of the package.
2010-08-06Medela IncThe product sterility may be compromised due to possible pinholes in the rigid tray of the package.
2010-08-06Medela IncThe product sterility may be compromised due to possible pinholes in the rigid tray of the package.
2010-03-15Medela IncThe non-sterile devices were erroneously packaged with instructions stating the devices are sterile and do not require cleaning before first use.

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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.