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Pump, Breast, Powered
FDA product code HGX · Class 2 · Obstetrics/Gynecology
1,052
Registered devices
5,556
Adverse events
8
Recalls
248
510(k) clearances
Devices with this code
Calypso Essentials — Ardo medical AGElvie Stride 2 Silicone Insert - 19mm — WILLOW INNOVATIONS, INC.Philips Avent Breast Pump Single — Philips Consumer Lifestyle B.V.Goldeep — Shenzhen TPH Technology Co., LtdHi bebe super — Bistos Co., Ltd.Viverity — COMPASS HEALTH BRANDS CORP.Little Martin's Drawer — EBZNS HOLDINGS LLCSpectra — UZINMEDICARE CO.,LTDSpectra — UZINMEDICARE CO.,LTDFreemie — DAO HEALTHNUK Co-branded Liberty Pump — DAO HEALTHAmeda, Inc. — AMEDA, INC.Motif Medical — CIMILRE CO .,LTDAmeda, Inc. — AMEDA, INC.Freemie — DAO HEALTHMedline — MEDLINE INDUSTRIES, INC.Ameda — AMEDA, INC.Little Martin's Drawer — EBZNS HOLDINGS LLCEnJoye Cordless Breast Pump — HYGEIA II MEDICAL GROUP INCCalypso Pump Unit — Ardo medical AGThe Pump by Babyation — Babyation Inc.Spectra — UZINMEDICARE CO.,LTDmonsao — Dongguan Rongfeng Medical Co., Ltd.Replacement Gen 3 27mm Flange — WILLOW INNOVATIONS, INC.
Recent 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, ma |
| 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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