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Hi bebe plus

Bistos Co., Ltd. · Model BT-100 · UDI-DI 00887529000168

HGX
1
510(k) clearances
5,568
Adverse events (2 deaths)
8
Recalls
115
Facilities

Description

Hi bebe plus BT-100 is a single user, home use electric breast pump that include massage and express mode and is capable of single and double pumping.

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.