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Spectra
UZINMEDICARE CO.,LTD · Model Spectra accessory(Duckbill Valve for Cara Cup) · UDI-DI 08809108014207
10
510(k) clearances
5,556
Adverse events (2 deaths)
8
Recalls
118
Facilities
Description
A collection of non-sterile items intended to be used in conjunction with the electric breast pump (not included) to assist mothers in extracting milk from the breast for collection and/or feeding an infant. It typically includes various items such as funnel-like flange, tubing, connectors, and milk collection cup. This is a reusable device.
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.