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Hi bebe super

Bistos Co., Ltd. · Model BT-150L · UDI-DI 08800012315022

HGX

510(k) clearances

5,556

Adverse events (2 deaths)

Recalls

118

Facilities

Description

This electrical breast pump is an electrically powered, software-controlled breast pump intended to express and collect milk from the breast of lactating women. The breast pump system is comprised of a motor unit and pump kit including tubing. This electrical breast pump is intended to be used by a single user. The user has the option to pump breast milk from a single breast (single pumping) or from both breasts (double pumping). And this pump also includes back flow protection and it is powered by a 12V DC adaptor or rechargeable lithium battery. This electrical breast pump has two operating functions: basic massage/expression function and program function to save an operating sequence.

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.