Youha
Ningbo Youhe Mother And Baby Products Co., Ltd. · Model YH-8006IV · UDI-DI 06972798250032
1
510(k) clearances
5,556
Adverse events (2 deaths)
8
Recalls
118
Facilities
Description
The Youha electric breast pump is a single-user, powered breast pump intended to be used by lactating women to express and collect milk from their breasts. YH-8004 and YH-8016 have both single (pumping from one breast) and double pumping (pumping from both breasts) configurations. YH-8006IV and YH-8015 have a single pumping configuration only.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2017-07-10 | AMEDA, INC. | Two specific lots was incorrectly manufactured containing a UK power adapter. |
| 2014-03-18 | Energizer Personal Care | Some of the power adapters outer casings may become loose and separate, resulting in a potential for electric shock. |
| 2011-01-10 | Medela Inc | The 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 |
| 2010-08-06 | Medela Inc | The product sterility may be compromised due to possible pinholes in the rigid tray of the package. |
| 2010-08-06 | Medela Inc | The product sterility may be compromised due to possible pinholes in the rigid tray of the package. |
| 2010-08-06 | Medela Inc | The product sterility may be compromised due to possible pinholes in the rigid tray of the package. |
| 2010-08-06 | Medela Inc | The product sterility may be compromised due to possible pinholes in the rigid tray of the package. |
| 2010-03-15 | Medela Inc | The 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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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.