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Youha

Ningbo Youhe Mother And Baby Products Co., Ltd. · Model YH-8011 · UDI-DI 06972798250063

HGX

510(k) clearances

5,556

Adverse events (2 deaths)

Recalls

118

Facilities

Description

The Youha, Bebebao, and Yiyadodo electric breast pumps are single-user, powered breast pump intended to be used by lactating women to express and collect milk from their breasts. THE ONE, YH-8012, BB-5020 and YY-5030 have both single (pumping from one breast) and double pumping (pumping from both breasts) configurations. YY-8011 and YH-8019 have a single pumping configuration only.A reciprocating diaphragm vacuum pump, driven by a microprocessor, generates the suction to extract the milk at vacuum levels up to 280 mmHg. The user interface for the THE ONE, YH-8012, BB-5020 and YY-5030 models consists of a front panel keypad and LCD display or LED display in which the user switches between modes and controls the vacuum pressure. The YY-5030 model does not have any visual indicators on the pump housing

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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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.