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Spectra
UZINMEDICARE CO.,LTD · Model Spectra breast shield kit(32mm) · UDI-DI 08809108018564
10
510(k) clearances
5,556
Adverse events (2 deaths)
8
Recalls
118
Facilities
Description
Spectra breast kit for breast pump including 32mm breast shield set. (excluding bottle set)
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.